Biosimilar Development News

31. Generic And Biosimilar Patent Settlements Save $423B 6/3/2025

    The Association for Accessible Medicines and its Biosimilars Council today released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent settlements in expediting patient access to lower-cost medicine. 

32. Sandoz Launches First And Only Interchangeable Denosumab Biosimilars In US, Providing New Affordable Treatment Options For Over 10 Million Patients^[1] 6/2/2025

    Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the US starting today. 

33. Alvotech And Advanz Pharma Extend Strategic Partnership To Commercialize Three Additional Biosimilars In Europe 5/28/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates.

34. US Food And Drug Administration (FDA) Grants Interchangeability Designation To Samsung Bioepis And Organon HADLIMA™ (adalimumab-bwwd) Injection 5/27/2025

    Samsung Bioepis Co., Ltd. and Organon & Co. today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira (adalimumab).

35. Bio-Thera Solutions And Hikma Pharmaceuticals Announce FDA Approval Of STARJEMZA® (ustekinumab-hmny) Injection, A Biosimilar Referencing STELARA® (ustekinumab) Injection 5/27/2025

    Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera's third FDA approved product.

36. Fresenius Receives Positive CHMP Opinion For Their Denosumab Biosimilar Candidates 5/27/2025

    Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of its biosimilar candidates to ⁽¹⁾ Prolia (denosumab) and ⁽²⁾ Xgeva (denosumab).

37. Lupin And Steincares Enter Into License And Supply Agreement For Ranibizumab In Latin America 5/26/2025

    Global Pharma major Lupin Limited (Lupin) today announced that it has entered into a license and supply agreement with SteinCares, a leading specialty healthcare company in Latin America, for commercialization of Lupin’s biosimilar ranibizumab across Latin America excluding Mexico and Argentina.

38. Xbrane Biopharma AB (publ) ('Xbrane' Or 'The Company') Updates On US FDA BLA (Biologics License Application) For Its Investigational Biosimilar Candidate To LUCENTIS (ranibizumab) 5/23/2025

    Xbrane re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to the FDA (US Food and Drug Administration) in December 2024.

39. Biosimilars Forum Submits Comments To Accelerate Safe And Effective Biosimilar Development By Modernizing The FDA And Eliminating Bureaucratic Inefficiencies 5/22/2025

    The Biosimilars Forum submitted comments to OMB Director Vought on commonsense, necessary steps to optimize the FDA and eliminate inefficiencies in its biosimilars approval program.

40. IGBA Welcomes ICH New Topic For Harmonisation: Framework For Determining Utility Of Comparative Efficacy Studies In Biosimilar Development Programs 5/21/2025

    The International Generic and Biosimilar medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs."