Articles from Samsung Bioepis Co., Ltd.

Samsung Bioepis Co., Ltd. today released its First Quarter 2026 Biosimilar Market Report, marking the twelfth edition of the Quarterly Biosimilar Market Report in the United States (US). The report provides an overview of the market status of all biosimilars available in the US, including approval and launch status, pricing (both Average Sales Price [ASP] and Wholesale Acquisition Cost [WAC]), and market uptake per molecule. The Deep Dive section in this edition provides an overview of the evolving US Pharmacy Benefit Manager (PBM) rebate contract model and how its frameworks may potentially impact the biosimilar market.

Samsung Bioepis Co., Ltd. today released its Fourth Quarter 2025 Biosimilar Market Report, marking the eleventh edition of the Quarterly Biosimilar Market Report in the United States (US). The report overviews the market status of all the biosimilars that are available in the US including approval and launch status, pricing (both Average Sales Price; ASP and Wholesale Acquisition Cost; WAC) after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product, and market uptakes per molecule. This issue features an interview with Dr. William Fleming, a former senior Medicare executive, on how payers are preparing for the upcoming implementation of the Maximum Fair Price (MFP) policy. As part of the Inflation Reduction Act (IRA), the CMS has been negotiating prices for some drugs with the highest Medicare expenditures. The newly negotiated prices of the first 10 selected drugs will become effective as of January 1, 2026.

Samsung Bioepis Co., Ltd. today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition of the Quarterly Biosimilar Market Report in the United States. The report offers insights into recent biosimilar pricing trends, market dynamics such as biosimilars adoption and price erosion, and the latest policy affecting biosimilars such as the Most-Favored-Nation (MFN) policy.

Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States. The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025.

Samsung Bioepis Co., Ltd. today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the US, as well as the price and market share trends since each biosimilar’s launch.

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.

Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively. In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk's interchangeability designation.