Uveitis, Intermediate

YUFLYMA® (adalimumab-aaty) was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available in the U.S. on July 2, 2023 The treatment will be available on CarePartners Specialty Pharmacy Program in late October and will make YUFLYMA accessible to over 10 million lives The inclusion of YUFLYMA creates greater accessibility to treatments for Americans JERSEY CITY, N.J.--(BUSINESS WIRE)-- Celltrion USA, Inc. (Celltrion USA) today announced its FDA-approved biosimilar, YUFLYMA® (adalimumab-aaty), has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira® (adalimumab) biosimilar. CarePartners and its strategic partners will offer and distribute YUFLYMA as the lowest net cost high-concentration Humira (adalimumab) biosimilar to over 10 million plan members. “Care Partners’ decision to add YUFLYMA to its formulary could benefit millions of Americans, bringing value to the healthcare system and patient communities,” said Thomas Nusbickel, Chief Commercial Offer at Celltrion USA. “We are dedicated to improving the lives of patients by expanding biosimilar access and affordability with treatment options backed by a strong, evidence-based efficacy-safety profile.” More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.1 YUFLYMA provides additional benefits of administration via a latex-free device and a longer shelf life due to its ability to maintain a stability at 77°F for a period up to 30 days, with protection from light. “We are excited to partner with Celltrion to offer a quality, high-concentration alternative to Humira at the lowest net-cost,” said Kam Ghazvini, RPh, Founder and CEO of CarePartners. “Partnering with Celltrion to offer YUFLYMA solidifies our cost saving initiatives for plan sponsors, employers, health plans, and other payers. We are excited to support Celltrion, a leading biotech company poised to be one of the leaders in the biosimilar landscape with a rich pipeline of blockbuster biosimilars in the years to come.” On September 29, the U.S. Food and Drug Administration (FDA) has approved additional strengths for YUFLYMA, a high-concentration (100mg/mL) and citrate-free formulation of Humira(adalimumab) biosimilar, in 20mg and 80mg strengths in the United States. <End> About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)2 YUFLYMA was the first high-concentration, low-volume, and citrate-free adalimumab biosimilar to receive European Commission approval in the European Union. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. Following the launch of 40mg/0.4mL in the U.S. in July 2023, two different types of dosage forms, 80mg/0.8mL, 20mg/0.2mL, were approved by the FDA on September 29, 2023. The full prescribing information can be found at: INDICATIONS YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa YUFLYMA® IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with YUFLYMA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUFLYMA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUFLYMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with YUFLYMA should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue YUFLYMA if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with YUFLYMA, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of YUFLYMA with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of YUFLYMA and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of YUFLYMA with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including YUFLYMA prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with YUFLYMA. In clinical trials of some adalimumab products, there was an approximate threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of YUFLYMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including YUFLYMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop YUFLYMA and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of YUFLYMA therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of YUFLYMA in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of YUFLYMA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of YUFLYMA therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using YUFLYMA in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with YUFLYMA, discontinue treatment. IMMUNIZATIONS Patients on YUFLYMA may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating YUFLYMA therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. Please see full Prescribing Information for YUFLYMA® (adalimumab-aaty) About Celltrion USA Celltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: About CarePartners CarePartners is a specialty pharmacy business focused on providing chronic and complex therapies including specialty infusion, specialty pharmacy, and ambulatory infusion services. The CarePartners team is made up of experienced clinicians and experienced support staff dedicated to providing patients with the highest quality service, leveraging a high-touch patient centric model. CarePartners offers innovative cost saving programs with positive clinical outcomes to plan sponsors, employers, unions, PBMs, and health plans. CarePartners is fully accredited and is licensed to service patients in all 50 states and DC. References Symphony Health, IQVIA YUFLYMA US prescribing information (2023)

First formal distribution agreement for YUSIMRY™, a biosimilar of Humira®, at $995 per carton (two 40 mg/0.8 mL autoinjectors) representing a discount of more than 85% compared to Humira Innovative distribution plan provides employers a low-cost, high-quality treatment option from Coherus and the highest quality of patient service and care from leading independent specialty pharmacy Superior Biologics REDWOOD CITY, Calif., July 13, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences Inc. (“Coherus”, Nasdaq: CHRS) and specialty pharmacy Superior Biologics, Inc. (“Superior Biologics”) today announced a national distribution agreement for YUSIMRY™ (adalimumab-aqvh) at a price of $995 per carton of two autoinjectors, a discount of more than 85% compared to Humira® (adalimumab), currently priced at $6,922 per carton of two pens. “Coherus is pleased to work with Superior Biologics for nationwide distribution of YUSIMRY, providing patients and their plan sponsors access to a high-quality, safe, and effective treatment at significant savings compared to Humira,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. “Superior Biologics is an ideal partner for the distribution of YUSIMRY based on their commitment to quality patient service and care, their extensive experience working with manufacturers, patients, physicians, and plan sponsors, and their nationwide reach. Through this unique distribution partnership, we can bring YUSIMRY immediately to patients throughout the United States.” “Patients deserve more affordable access to specialty drugs to treat their life-altering illnesses,” said Robert Cappa, RPh, President of Superior Biologics. “The national distribution of YUSIMRY through this agreement fulfills our shared vision with Coherus of delivering affordable solutions to patients with health challenges. This distribution partnership is an important and innovative step toward creating new options in the marketplace for patients to access specialty drugs, starting with the delivery of YUSIMRY at a fraction of the cost of Humira. It’s a game-changer for both patients and employers who have faced significant challenges from the skyrocketing costs of specialty drugs.” Superior Biologics specializes in high-touch patient services and delivers quality care for a variety of disease states including rheumatology, gastroenterology, and neurology. An unmatched track record for meeting patients’ needs has led to high levels of customer satisfaction and allowed Superior Biologics to become a trusted resource for prescribing physicians. Coherus first announced the release of YUSIMRY on July 3, 2023 at an annual price of less than $13,000 compared to nearly $90,000 for Humira® (adalimumab) based on the company’s investment in robust large-scale manufacturing, passing the savings on directly to patients in need. The agreement is the first between the two companies, marking an innovative distribution model that will serve patients effectively and allow employers to achieve significant savings in their specialty drug costs. About YUSIMRY YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. IMPORTANT SAFETY INFORMATION AND INDICATIONS YUSIMRY™ (adalimumab-aqvh) is biosimilar* to Humira® (adalimumab injection). WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Patients treated with YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients: 1. with chronic or recurrent infection; 2. who have been exposed to TB; 3. with a history of opportunistic infection; 4. who resided in or traveled in regions where mycoses are endemic; 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start YUSIMRY during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a tumor necrosis factor (TNF) blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of YUSIMRY with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions as well as the lack of demonstrated benefit of such combinations. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of YUSIMRY treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen plus ultraviolet A light (PUVA) therapy, for the presence of NMSC prior to and during treatment with YUSIMRY. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop YUSIMRY and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after YUSIMRY treatment. Discontinue YUSIMRY and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming YUSIMRY after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including adalimumab, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering YUSIMRY for patients with these disorders; discontinuation of YUSIMRY should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab. Consider stopping YUSIMRY if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with YUSIMRY may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on YUSIMRY should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating YUSIMRY therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to YUSIMRY in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Rheumatoid Arthritis: YUSIMRY is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: YUSIMRY is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: YUSIMRY is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: YUSIMRY is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: YUSIMRY is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis: YUSIMRY is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. YUSIMRY should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of YUSIMRY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Click for YUSIMRY™ Full Prescribing Information, including Boxed Warning and Medication guide About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. The Biologics License Application for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA. Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®. About Superior Biologics Founded in 2012, Superior Biologics, Inc. is a leading national provider of specialty pharmacy and home infusion therapy services to patients suffering from a wide variety of chronic diseases. Superior Biologics provides innovative and cost-effective pharmacy and in-home nursing infusion services that result in optimal therapeutic outcomes and deliver best-in-class patient results. By offering the highest levels of service and quality, Superior Biologics has become a trusted partner of top physicians and thought leaders from the most prestigious medical centers and universities across the country. Superior Biologics’ pharmacies are accredited by the Utilization Review Accreditation Commission (URAC), The Joint Commission (TJC) and the Accreditation Commission for HealthCare (ACHC). Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the effectiveness of its distribution model. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance, or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to our existing and potential collaboration partners, the risks and uncertainties inherent in the clinical drug development process; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, the risk of FDA review issues; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023, filed with the Securities and Exchange Commission on May 8, 2023, including the section therein captioned “Risk Factors” and in other documents that Coherus files with the Securities and Exchange Commission. UDENYCA®, CIMERLI® and YUSIMRY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information: For Investors: Marek Ciszewski, J.D., SVP Investor Relations IR@coherus.com For Media: John Brandt, Rokk Solutions coherus@rokksolutions.com 202-805-1830 Superior Biologics Contact information: Peter Fricke media@superiorbiologics.com (847) 924-2584 A photo accompanying this announcement is available at YUSIMRY™ (adalimumab-aqvh) product image YUSIMRY™ (adalimumab-aqvh) - list price $995 per carton of two 40 mg/0.8 mL autoinjectorsSee for YUSIMRY™ Full Prescribing Information, including Boxed Warning and Medication guide.

BRIDGEWATER, N.J. and BENGALURU, India, July 3, 2023 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, today announced that HULIO® (adalimumab-fkjp) injection, a biosimilar to Humira® (adalimumab), is now available to patients in the United States after five years of experience in Europe and two years in Canada. Continue Reading Biocon Biologics, which recently announced its acquisition of Viatris' global biosimilars business, has secured multiple biosimilar approvals in the U.S., Europe, and over 100 countries across the globe. With the acquisition of Viatris' biosimilars business, Biocon Biologics can now help provide patients and healthcare professionals with more accessible and affordable treatment options in diabetes, cancer and immunology therapeutic areas. "The launch of HULIO®, our biosimilar adalimumab, in the United States is an important milestone for Biocon Biologics." Tweet this "The launch of HULIO®, our biosimilar adalimumab, in the United States is an important milestone for Biocon Biologics as it expands our well-known biosimilar product offering to patients in the United States. This launch builds on our strong presence in oncology and diabetes and re-affirms our commitment to enabling affordable access to biologics," said Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. "Biocon Biologics is pleased to make HULIO®, a patient-friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases. There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection. Designed and built with patients in mind, healthcare professionals and patients don't have to miss a beat with HULIO®; they simply, 'Click, Click, Go,'" said Mathew Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd. See Full Prescribing Information including BOXED WARNING regarding Serious Infections and Malignancy. To provide broad access for patients, Biocon Biologics is offering two options to health plans and pharmacy benefit managers. HULIO® is available at a list price (Wholesale Acquisition Cost) of 5% below the current Humira list price. Adalimumab-fkjp is also available at a list price of approximately 85% below the current Humira list price. HULIO® meets the rigorous biosimilar approval standards of the FDA. Like Humira, HULIO® is citrate-free and is made without natural rubber latex (to help reduce hypersensitivity reactions). Biocon Biologics also offers HULIO360, a robust patient support program, which includes benefits verification and prior authorization support, copay assistance, a bridge program for eligible patients, and at-home nurse injection training. To learn more, visit . HULIO is a registered trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed to the Viatris Companies. Effective November 29, 2022, Viatris completed the sale of substantially all of its biosimilars portfolio (including related product trademarks) to Biocon Biologics Limited and its subsidiaries ("Biocon") and the relevant marketing authorizations are in the process of being transferred. Viatris Inc. and its subsidiaries ("Viatris") are not affiliates of Biocon but are providing certain transition services to Biocon following the transaction completion date, such as operating websites (including this site) relating to the biosimilars portfolio on Biocon's behalf. Hulio360 is a trademark of Fujifilm Kyowa Kirin Biologics Co., Ltd., licensed to Biosimilar Collaborations Ireland Ltd., a Biocon Biologics company. Copyright © 2023 Biocon Biologics Inc. All rights reserved. IMPORTANT SAFETY INFORMATION AND INDICATIONS WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HULIO are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HULIO if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HULIO use and during therapy. Initiate treatment for latent TB prior to HULIO use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HULIO prior to initiating therapy in patients: 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) with a history of opportunistic infection, 4) who resided in or traveled in regions where mycoses are endemic, 5) with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HULIO, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy Do not start HULIO during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully, and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HULIO with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6- mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of HULIO treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HULIO. In HULIO clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop HULIO and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including HULIO, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after HULIO treatment. Discontinue HULIO and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HULIO after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering HULIO for patients with these disorders; discontinuation of HULIO should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping HULIO if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on HULIO should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HULIO therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HULIO in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Rheumatoid Arthritis: HULIO is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: HULIO is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: HULIO is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: HULIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn's Disease: HULIO is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: HULIO is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HULIO has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis: HULIO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HULIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Please see Full Prescribing Information including BOXED WARNING. About Biocon Limited: Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on Twitter: @bioconlimited for company updates. Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world- class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. BBL has acquired the global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., EU, Australia, Canada, Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry.. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on Twitter: @BioconBiologics for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics, Inc