hepatosplenic T-cell lymphoma

Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and immunogenicity profiles were comparable between switching group and continuous reference product Humira group 52-week results from SB17 Phase 3 study demonstrated long-term efficacy, safety, and immunogenicity of SB17 compared to reference ustekinumab, including switching from ustekinumab to SB17 INCHEON, Korea, March 09, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. presented two new study results for its immunology portfolio – SB5, a biosimilar to Humira1 (adalimumab), and SB17, a proposed biosimilar to Stelara2 (ustekinumab) – at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States. “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting. We will continue to work towards generating robust scientific evidence that demonstrate comparable efficacy and safety of biosimilars to reference products, including data for switching from reference products to biosimilars,” said Ilsun Hong, Vice President, Production Evaluation Team Leader of Samsung Bioepis. SB5, approved by the U.S. Food and Drug Administration (FDA) under the brand name HADLIMA™ (adalimumab-bwwd) as a biosimilar to Humira, is being reviewed by the FDA as an interchangeable biosimilar to Humira based on the Phase 4 study results. The Phase 4 randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter study (NCT05510063) assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups of adult patients with moderate to severe plaque psoriasis: patients who switched between reference product Humira and the high-concentration formulation SB5 (40 mg/0.4 mL) versus those receiving reference product continuously. The interchangeability study met primary endpoints of AUCtau (week 23-25) and Cmax (week 23-25), demonstrating comparability between the switching group and continuous reference product treatment group. Other endpoints including efficacy, safety, and immunogenicity were also comparable. SB5 was first approved by the FDA in July 2019 under the brand name HADLIMA (adalimumab-bwwd) as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022. HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon. In addition, Samsung Bioepis presented the final 52-week results from the Phase 3 study for SB17, comparing the long-term efficacy, safety, and immunogenicity between three treatment groups: SB17-treated group, reference ustekinumab-treated group, and switched group from reference ustekinumab to SB17 at Week 28. The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52. SB17 was recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2024 under the brand name PYZCHIVA™. In the United States, the Biologics License Application (BLA) for SB17 is under review by the FDA. If approved, SB17 will be commercialized by Sandoz in Europe and the U.S. Details of the Samsung Bioepis’ abstracts are as follows: Presentation TitlePresentation DetailsInterchangeability of SB5 and Adalimumab Reference Product in Patients with Moderate to Severe Chronic Plaque PsoriasisSession: PosterExhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PMAbstract Number: 50522Authors: Steven R. Feldman, Skaidra Valiukevičienė, Grazyna Pulka, Elzbieta Krolikowska, Pawel Brzewski, Malgorzata Janczylo-Jankowska, Bartlomiej Kwiek, Lidia Rajzer, Soyeon Kim, Yumin Baek, Hyuna LeeClinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week ResultsSession: PosterExhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PMAbstract Number: 49140Authors: Steven R. Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Jiyoon Lee, Minkyung Lee, Young Hee Rho About HADLIMA (adalimumab-bwwd) Injection 40 mg/0.4 mL and 40 mg/0.8mL HADLIMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (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: HADLIMA 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: HADLIMA 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: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: HADLIMA 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: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use:The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA 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. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. SELECTED SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with adalimumab products, including HADLIMA, 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 HADLIMA 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 HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA 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 HADLIMA prior to initiating therapy in patients: with chronic or recurrent infection who have been exposed to TB with a history of opportunistic infection who resided in or traveled in regions where mycoses are endemic 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 HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start HADLIMA 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 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 HADLIMA with other biologic DMARDs (eg, 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 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 HADLIMA 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 and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. 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 HADLIMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including HADLIMA, 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 HADLIMA treatment. Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA 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 HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. 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 HADLIMA 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 HADLIMA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA 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 adalimumab products 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 (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Before prescribing HADLIMA, please read the accompanying Full Prescribing Information, including the Boxed Warning about serious infections and malignancies, Medication Guide and Instructions for Use. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn. _________________________ 1 Humira is a trademark registered in the US by AbbVie Biotechnology Ltd. 2 Stelara is a trademark of Johnson & Johnson.

JERSEY CITY, N.J.--( BUSINESS WIRE )--Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn’s disease, hidradenitis suppurativa, and plaque psoriasis (see full indications below). " America’s veterans deserve access to quality medicines at a lower cost. We are proud to support the more than nine million people enrolled in the VA healthcare system through this collaboration, which is a great example of industry and public sector working together,” said Kevin Ali, Organon CEO. “ We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the US on its formulary." HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy. HADLIMA is FDA approved in both citrate-free high concentration (40 mg/0.4 mL), the most-utilized formulation of the originator, and citrate-containing low concentration (40 mg/0.8 mL) formulations to provide patients with continuity of care. Intended to fit into a patient’s lifestyle, HADLIMA is available in both a pre-filled syringe and autoinjector option. The HADLIMA TM PushTouch™ Autoinjector was specifically designed with the patient in mind, with a thin 29G needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface. The PushTouch Autoinjector has been awarded the Arthritis Foundation’s Ease of Use Certification, which recognizes products that make life easier for those living with arthritis and other functional limitations via lab and patient testing by the Intuitive Design Applied Research Institute (IDARI). 1 Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. See additional safety information below. About HADLIMA™ (adalimumab-bwwd) Injection, 40 mg/0.4 mL and 40 mg/0.8 mL HADLIMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (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: HADLIMA 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: HADLIMA 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: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: HADLIMA 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: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use : The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA 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. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. SELECTED SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with adalimumab products, including HADLIMA, 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 HADLIMA 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 HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA 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 HADLIMA prior to initiating therapy in patients: with chronic or recurrent infection who have been exposed to TB with a history of opportunistic infection who resided in or traveled in regions where mycoses are endemic 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 HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start HADLIMA 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 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 HADLIMA with other biologic DMARDs (eg, 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 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 HADLIMA 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 and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. 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 HADLIMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including HADLIMA, 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 HADLIMA treatment. Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA 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 HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. 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 HADLIMA 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 HADLIMA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA 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 adalimumab products 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 (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Before prescribing HADLIMA, please read the accompanying Prescribing Information , including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . Cautionary Note Regarding Forward-Looking Statements Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations regarding HADLIMA™ and its selection for inclusion in the VA National Formulary for veterans. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as "may," “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on Organon’s current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon’s plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect Organon’s future results include, but are not limited to, an inability to fully execute on the product development and commercialization plans for HADLIMA in the United States due to Organon’s inability to realize the benefits of its SB5 HADLIMA biosimilar; any future discontinuation of the inclusion of HADLIMA in the VA National Formulary for veterans; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to Organon’s products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site ( www.sec.gov ). 1 HADLIMA Prefilled syringe and autoinjector Ease of Use Certification. Arthritis Foundation. July 1, 2023. Accessed February 12, 2024. https://www.arthritis.org/partnership/ease-of-use-certification

A post hoc analysis from the EXXELERATE Phase 4 trial showed that 65.7 percent of CIMZIA-treated patients with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels achieved low disease activity at Week 1041 CIMZIA maintained drug concentrations and achieved Low Disease Activity regardless of RF levels in patients with established RA until the end of the study period (w104)1 In patients with RA and high RF levels, who are at increased risk of disease progression, CIMZIA has the potential to deliver meaningful outcomes1 ATLANTA, Nov. 11, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, will present a post hoc analysis of the EXXELERATE trial examining the efficacy of CIMZIA ® (certolizumab pegol) and adalimumab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (RF) levels. The data are being presented at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, November 10–15.1 In the initial EXXELERATE trial comparing the efficacy of CIMZIA and adalimumab, the primary endpoints of superiority were not met. In the post hoc analysis, efficacy outcomes in CIMZIA and adalimumab were assessed in patients with RA across RF subgroups.1 Patients were randomized 1:1 to CIMZIA 200 mg every two weeks plus methotrexate (MTX) or adalimumab 40 mg every two weeks plus MTX. At Week 12, patients were classified as responders or non-responders, non-responders were switched to the other TNFi with possible follow-up to Week 104. Results showed that for patients in the higher RF quartile, 65.7 percent of 453 patients treated with CIMZIA and 48.3 percent of 454 patients treated with adalimumab achieved low disease activity at Week 104.1 "It is well known that high rheumatoid factor (RF) levels are associated with a poor prognosis.2 In addition, high RF levels may lead to decreased drug concentrations of monoclonal antibodies and potentially lower response to TNFis in patients with rheumatoid arthritis (RA).1,3 The results of this analysis highlight how, through its fragment crystallizable (Fc)-free molecular structure, certolizumab pegol maintained constant blood concentrations and therapeutic responses regardless of RF levels," said Professor Josef Smolen, Emeritus Professor of Internal Medicine, Medical University of Vienna, Division of Rheumatology, Vienna, Austria. "These data may be of clinical relevance in the context of using a personalized medicine approach for patients with RA and high RF levels."1 RA is a chronic disease that causes inflammation throughout the body and commonly presents as joint pain, swelling, and deformity, which results in a decline in physical function and quality of life.4,5 It is estimated that, as of 2021, approximately 1.5 million people in the United States live with this disease.6 High RF is associated with a more aggressive and destructive disease course, which is often more difficult to treat.7 One reason for this is the high levels of RF autoantibodies binding with the Fc parts of TNFis to form large immune complexes that are then degraded by macrophages, resulting in lower bioavailability of biologic drugs.8,9 To treat RA when high RF levels are present, American College of Rheumatology guidelines recommend biologic disease-modifying anti-rheumatic drugs (bDMARDS) if there is no observed improvement with MTX treatment.10 However, many bDMARDs such as TNFis contain an Fc region that RF antibodies bind to, which can result in a lower clinical efficacy and the need for additional interventions.11,12,13 The distinctive, FC-free structure of CIMZIA means RF may not bind to the drug, allowing its concentration to remain stable over time.14 "At UCB, we aspire to achieve long-lasting drug-free remission for as many patients living with rheumatoid arthritis (RA) as possible," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of U.S., UCB. "The data presented at this year's ACR Convergence demonstrate the benefits of certolizumab pegol, as it continues to deliver value for those with high unmet need, late into its lifecycle and beyond. We are excited to continue exploring its scientific potential as a personalized solution for RA patients with high levels of Rheumatoid Factor (RF)."1 For further information, contact UCB: Investor Relations Antje Witte T: +32.2.559.94.14 Email: [email protected] US Communications Ally Funk T: +1.678.365.6321 Email: [email protected] About the EXXELERATE trial methodology and patient population In patients with RA, high RF levels are considered a poor prognostic factor and are associated with higher disease activity, risk of radiographic progression, and decreased response to TNF inhibitors (TNFis).7 Recent data suggest that patients with RA and high RF levels may achieve and maintain greater clinical improvement with TNFis without a crystallizable fragment (Fc) compared with TNFis with an Fc.12 In this post hoc analysis of the EXXELERATE trial, we assessed efficacy outcomes of CIMZIA (CZP), a PEGylated, Fc-free TNFi, and adalimumab (ADA; Fc-containing TNFi) in patients with RA across different RF levels.1 About CIMZIA® in the U.S. 15 CIMZIA® is the only Fc-free, PEGylated anti-TNF (tumor necrosis factor). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. CIMZIA is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. CIMZIA is indicated for the treatment of moderate-to-severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. In addition, CIMZIA is indicated for reducing signs and symptoms of Crohn's disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below. IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S. CONTRAINDICATIONS CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria. SERIOUS INFECTIONS Patients treated with CIMZIA 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 CIMZIA 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 CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA 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 CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; 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 CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start CIMZIA 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. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients. Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients. In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population. Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population. 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 CIMZIA. 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. Carefully assess the risks and benefits of treating with CIMZIA in these patient types. Cases of acute and chronic leukemia were reported with TNF blocker use. HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Exercise caution and monitor carefully. HYPERSENSITIVITY Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Test patients for HBV infection before initiating treatment with CIMZIA. Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment. Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA. Consider stopping CIMZIA if significant hematologic abnormalities occur. DRUG INTERACTIONS Do not use CIMZIA in combination with other biological DMARDS. AUTOIMMUNITY Treatment with CIMZIA 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 CIMZIA should not receive live or live-attenuated vaccines. ADVERSE REACTIONS The most common adverse reactions in CIMZIA clinical trials (≥8%) were: upper respiratory infections (18%), rash (9%), and urinary tract infections (8%). For full prescribing information, please visit About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. 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UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. Abbreviations: ACR: American College of Rheumatology, bDMARDS: biologic disease-modifying anti-rheumatic drugs, AS: Ankylosing spondylitis, axSpA: Axial spondyloarthritis, CRP: C-reactive protein, DMARDs: disease-modifying antirheumatic drugs, EEA: European Economic Area, EU: European Union, MRI: Magnetic Resonance Imaging, NSAIDS: non-steroidal anti-inflammatory drugs, HBV: hepatitis B, Fc: fragment crystallizable, MTX: methotrexate, RA: rheumatoid arthritis, RF: rheumatoid factor, TNFis: tumor necrosis factor-α inhibitors, UCB: Union Chimique Belge. 1 Smolen J, Taylor P, Tanaka Y, et al. Do High RF Titers Impact Response to TNF Inhibitors? Comparison of Certolizumab Pegol and Adalimumab in Patients with RA and High Titers of RF: A Post Hoc Analysis of a Phase 4 Trial. Arthritis Rheumatol. 2023;75 (suppl 9). ACR Convergence 2023. 2148. 2 Albrecht K, Zink A. Poor prognostic factors guiding treatment decisions in rheumatoid arthritis patients: a review of data from randomized clinical trials and cohort studies. Arthritis Res Ther. 2017;19(1):1-8. 3 Tiwari V, Jandu JS, Bergman MJ. Rheumatoid Factor. In: StatPearls [Internet]. Treasure Island. 2023. 4 Sparks JA. Rheumatoid Arthritis. Ann Intern Med. 2019;170(1):ITC1-ITC16. 5 Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388:2023–38. 6 Arthritis Foundation (October 15, 2021). Rheumatoid Arthritis: Causes, Symptoms, Treatments and More. Available at: . Last accessed: October 2023. 7 Watanabe R, Hashimoto M, Murata K, et al. Prevalence and predictive factors of difficult-to-treat rheumatoid arthritis: the KURAMA cohort. Immunol Med. 2022;46(1):35-44. 8 Laurent L, Anquetil F, Clavel C, et al. IgM rheumatoid factor amplifies the inflammatory response of macrophages induced by the rheumatoid arthritis-specific immune complexes containing anticitrullinated protein antibodies. Ann Rheum Dis. 2015;74(7):1425-31. 9 Aletaha D, Alasti F, Smolen JS. Rheumatoid factor determines structural progression of rheumatoid arthritis dependent and independent of disease activity. Ann Rheum Dis. 2012;72(6):875-80. 10 Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-39. 11 Takeuchi T, Miyasaka N, Inui T, et al. High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study. Arthritis Res Ther. 2017;19(1):194. 12 Nakayama Y, Watanabe R, Murakami K, et al. Differential efficacy of TNF inhibitors with or without the immunoglobulin fragment crystallizable (Fc) portion in rheumatoid arthritis: the ANSWER cohort study. Rheumatol Int. 2022;42(7):1227-34. 13 Calvo Gutierrez J, Ortega Castro R, Ábalos-Aguilera MC, et al. Impact of baseline rheumatoid factor titers and anti-TNF molecular structure on the retention rate in patients with rheumatoid arthritis. Ann Rheum Dis. 2023;82:1400-1. 14 Senolt L. Emerging therapies in rheumatoid arthritis: focus on monoclonal antibodies. F1000Res. 2019;8:F1000 Faculty Rev-1549. 15 CIMZIA (certolizumab pegol) US Prescribing Information. Available at: Cimzia_09_11_2019_en.pdf (ucb.com). Last accessed: November 2023. CIMZIA® is a registered trademark of the UCB Group of Companies. All other trademarks are the property of their respective holders. ©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. Date of preparation: November 2023. SOURCE UCB