Biosimilar Development News

31. Hikma Pharmaceuticals Announces The Launch Of STARJEMZA (Ustekinumab-Hmny) Injection, A Biosimilar Referencing STELARA (Ustekinumab) Injection 11/6/2025

    Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced the launch of STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing STELARA (ustekinumab) Injection.

32. In A Landmark Industry Transaction, Evotec Signs Agreement With Sandoz, Resulting In Payments Potentially Over US $650M Plus Royalties 11/4/2025

    Evotec SE, a life science company that is pioneering the future of drug discovery and development, today announced the successful signing of the sale of the Just - Evotec Biologics Toulouse site to Sandoz AG, a global leader in generic and biosimilar medicines.

33. Sandoz Boosts In-House Biosimilars Capabilities By Signing Agreement To Acquire Just-Evotec Biologics EU SAS In Toulouse 11/4/2025

    Sandoz, the global leader in affordable medicines, today announced a strategic agreement with Evotec SE to acquire all issued and outstanding equity interests of Just-Evotec Biologics EU SAS (JEB SAS) which includes the Toulouse manufacturing site.

34. Boston Oncology Arabia And Local Content & Government Procurement Authority Sign Agreement To Localize Advanced Biologic Medicines In Saudi Arabia 11/4/2025

    In a major step toward advancing pharmaceutical local content and national drug security, BOSTON ONCOLOGY ARABIA and the Local Content & Government Procurement Authority (LCGPA) have signed an agreement to localize the manufacture of two biosimilar medicines within the Kingdom.

35. First Patient Included In The Pivotal Clinical Trial For Xdivane 11/4/2025

    Xbrane Biopharma AB (publ) (“Xbrane”) (Nasdaq Stockholm: XBRANE) today announces that the first patient has been enrolled in the pivotal clinical trial for Xdivane (the biosimilar candidate for nivolumab).

36. Policy Engagement To Break Down Barriers To Access And Build Resilient Health Systems At Viatris 11/4/2025

    Public policies are central factors in determining healthcare interventions and access to medicines and treatment.

37. Newly Established Samsung Epis Holdings To Drive Growth For Samsung Bioepis And A New Subsidiary 11/2/2025

    Samsung Epis Holdings Co., Ltd. today announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS).

38. Alvotech Provides Update On The Status Of U.S. Biologics License Application For AVT05 11/2/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S.

39. U.S. FDA Grants Interchangeability Designation To Celltrion's denosumab Biosimilars, STOBOCLO® (denosumab-bmwo) And OSENVELT® (denosumab-bmwo) 10/30/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications.

40. Vizient Applauds FDA's Recent Actions To Accelerate Biosimilar Development And Lower Costs 10/30/2025

    Vizient commends the U.S. Food and Drug Administration (FDA) for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater clarity on when comparative efficacy studies (CES) are not required for biosimilar approval which should reduce burdens currently associated with biosimilar approvals in certain circumstances.