Bronchiolitis Obliterans

INCHEON, Korea I February 24, 2025 I Samsung Bioepis Co., Ltd. today announced that PYZCHIVA ® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Through Samsung Bioepis’ commercialization partner Sandoz, PYZCHIVA is available to patients across US starting today in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials. “The launch of PYZCHIVA is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US. The expanded treatment options in the market would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system,” said Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis. “We remain steadfast in our commitment to serve patients in need through our continued innovation to make medicine more accessible.” Samsung Bioepis and Sandoz entered into a commercialization agreement for PYZCHIVA in September 2023 for the US. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc. Samsung Bioepis has a total of 11 biosimilars in its products and pipeline portfolio across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, Samsung Bioepis has 10 biosimilars approved in the US and five commercially available. About PYZCHIVA® (ustekinumab-ttwe) injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or intravenous (130 mg/26 mL solution) use PYZCHIVA (ustekinumab-ttwe) is indicated for: SELECTED IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA. WARNINGS AND PRECAUTIONS Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following: Avoid initiating treatment with PYZCHIVA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of PYZCHIVA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with PYZCHIVA and discontinue PYZCHIVA for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with PYZCHIVA. Avoid administering PYZCHIVA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering PYZCHIVA. Consider anti-tuberculosis therapy prior to initiation of PYZCHIVA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving PYZCHIVA for signs and symptoms of active tuberculosis during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical studies. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving PYZCHIVA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue PYZCHIVA. Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with PYZCHIVA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue PYZCHIVA. Immunizations Prior to initiating therapy with PYZCHIVA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with PYZCHIVA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with PYZCHIVA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving PYZCHIVA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of PYZCHIVA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue PYZCHIVA and institute appropriate treatment. Most common adverse reactions are: Please see Full Prescribing Information for PYZCHIVA ® (ustekinumab-ttwe) HERE , which includes the Boxed Warning, 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, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . SOURCE: Samsung Bioepis

BRIDGEWATER, N.J. and BENGALURU, India, Feb. 24, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced that YESINTEK™ (ustekinumab-kfce) is now available to patients in the United States, and is one of the first Stelara® (ustekinumab) biosimilar market entrants in the country. Continue Reading YESINTEK is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases. YESINTEK will be available in all the same formulations currently provided by Stelara. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. YESINTEK is approved for the treatment of common chronic autoimmune diseases. Post this Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population." Laura Wingate, Chief Education, Support & Advocacy Officer of the Crohn's & Colitis Foundation, said: "The burden of Crohn's disease and ulcerative colitis on patients' daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available." YESINTEK will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0. YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling associated immune mediated diseases. Clinical studies showed that YESINTEK is a biosimilar to Stelara® and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with Stelara®. YESINTEK received U.S. Food and Drug Administration (FDA) approval in December 2024. Josh Salsi, Head of North America, Biocon Biologics Inc., said: "For healthcare providers, switching to YESINTEK offers a seamless treatment experience covering the same indications and dosing options. Patients can feel confident that YESINTEK comes from Biocon Biologics, a company with extensive biosimilar expertise in immunology." For more information and resources, please visit . Health care professionals can access more information at . About YESINTEK The approval for YESINTEK (ustekinumab-kfce) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESINTEK is highly similar to Stelara®. In a Phase 3 STELLAR-2 Study, YESINTEK was compared with Stelara® in patients with moderate-to-severe chronic Plaque Psoriasis. The study demonstrated that there were no clinically meaningful differences between YESINTEK and Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy Active psoriatic arthritis (PsA) Moderately to severely active Crohn's Disease (CD) Moderately to severely active ulcerative colitis Pediatric patients 6 years and older with: Moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy Active psoriatic arthritis (PsA) CONTRAINDICATIONS Clinically significant hypersensitivity to ustekinumab or to any of the excipients in YESINTEK. WARNINGS AND PRECAUTIONS: Infections: Serious infections have occurred. Avoid starting YESINTEK during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue YESINTEK until the infection resolves. Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with YESINTEK. Initiate treatment of latent TB before administering YESINTEK. Malignancies: Ustekinumab may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Hypersensitivity Reactions: If an anaphylactic or other clinically significant hypersensitivity reactions occurs, institute appropriate therapy and discontinue YESINTEK. Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly and discontinue YESINTEK. Immunizations: Avoid use of live vaccines in patients during treatment with YESINTEK. Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. If diagnosis is confirmed, discontinue YESINTEK and institute appropriate treatment. Please refer to full Prescribing Information for YESINTEK for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or . About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company 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. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. 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 X (formerly Twitter) @bioconlimited and LinkedIn: Biocon 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. YESINTEK is a registered trademark of Biocon Biologics Limited All other trademarks, registered or unregistered, are the property of their respective owners. SOURCE Biocon Biologics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, Dec. 8, 2024 /PRNewswire/ -- December 8, 2024, Abbisko Therapeutics (HKEX: 02256) announced the presentation of preliminary Phase 2 study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) who have either progressed or not responded to one or more prior lines of therapy. The presentation took place at the 66th ASH Annual Conference, held December 7-10, 2024, in San Diego, California. Despite most enrolled patients having not yet completed the 6-month treatment cycle required for cGvHD response evaluation, preliminary data from the subset of patients receiving 20mg QD shows that pimicotinib achieved an ORR of 64%. Continue Reading Prof. Xiaodong Mo, Chief Physician of the Department of Hematology, Peking University People's Hospital, reporting on the scene As of November 22, 2024, a preliminary 64% ORR was observed in the subset of patients receiving pimicotinib 20mg QD, with responses observed in all affected organs, including the gastrointestinal tract, oral cavity, eyes, liver, joints and fascia, esophagus, skin, and lungs. In many patients with cGvHD, pulmonary manifestations, such as shortness of breath and diminished lung function, can occur and finally be diagnosed as cGvHD-associated BOS (Bronchiolitis Obliterans Syndrome), which is one of the major challenges in the treatment of cGvHD urgently requiring new therapies. During the oral presentation, researchers highlighted specific lung response results in six subjects at the latest data cut-off: one subject achieved an 11% increase in FEV1 (forced expiratory volume in the first second), one subject's FEV1 recovered to more than 75% after treatment thereby returning to normal levels, and the remaining four subjects saw improvements in the NIH Lung score with significant improvements in shortness of breath. Together, data demonstrate the clinical efficacy of pimicotinib for the treatment of cGvHD-associated BOS. As of the November 22, 2024 data cut-off, the majority of enrolled patients have not yet completed the 6-month treatment cycle to determine the primary endpoint of the study, suggesting the possibility of improved outcomes with longer-term treatment with pimicotinib. The results show that pimicotinib demonstrated robust clinical efficacy and is well tolerated in heavily pre-treated patients with cGvHD. Rapid and durable responses were observed across both inflammation-dominated and fibrosis-dominated organs, accompanied by patient-reported reductions in organ-specific symptom burden. The majority of adverse events were Grade 1 and reversible. Based on latest clinical experience, pimicotinib represents a potentially promising and novel therapeutic option for the management of cGvHD. About Pimicotinib (ABSK021) Pimicotinib (ABSK021), which is being independently developed by Abbisko Therapeutics, is a novel, orally administered, highly selective, and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designations (BTD) by China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) and priority medicine (PRIME) designation from the European Medicines Agency (EMA) for the treatment of patients with TGCT that are not amenable to surgery. Pimicotinib is also currently being evaluated for the treatment of patients with chronic Graft-versus-Host Disease. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit for more information. SOURCE Abbisko WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED