Biosimilar Development News

  1. U.S. Generic & Biosimilar Medicines Save $496B In Just 1 Year 9/10/2026

    The Association for Accessible Medicines and the Biosimilars Council today released the 2026 U.S. Generic & Biosimilar Medicines Savings Report – Forward for America. AAM’s annual savings report highlights that generic and biosimilar medicines created $496B in savings in 2025 for patients and the overall healthcare system.

  2. Henlius Open Day 2026: Systematic Global Expansion Drives C-MNC Vision, Innovation Fuels New Peaks 9/9/2026

    Henlius successfully hosted its Open Day 2026 event with great fanfare. The company's management team gathered together with leading experts and scholars from across the industry to engage in in-depth discussions centered on Henlius's "Globalization 2.0" strategy, the global value of biosimilars, the latest advancements in innovative R&D, future strategic planning, and cutting-edge technology and therapeutic modalities.

  3. Sandoz Invests In New Drug Substance Facility In Ljubljana, Slovenia, To Expand Biosimilar Manufacturing Capacity 9/8/2026

    Sandoz, the global leader in affordable medicines, today announces plans to build a new biosimilar drug substance facility in Ljubljana, Slovenia.

  4. Samsung Bioepis Gains Marketing Approval In Japan For 130mg Intravenous Infusion Of Ustekinumab Biosimilar 9/3/2026

    Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Intravenous Infusion 130mg 「NIPRO」, a biosimilar referencing Stelara1 (ustekinumab), indicated for an induction therapy for moderate-to-severe active Crohn’s disease where other treatments are ineffective.

  5. Cipla Announces Exclusive Partnership With Qilu Pharmaceutical For The Licensing And Supply Of Biosimilar To Keytruda® (Pembrolizumab) In The US 9/3/2026

    Invagen Pharmaceuticals Inc, a wholly owned subsidiary of Cipla Limited (BSE: 500087) (NSE: CIPLA) today announced that it has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. (hereinafter referred to as Qilu), for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda® (pembrolizumab), for the United States.

  6. Alvotech Announces FDA Acceptance For Review Of Biologics License Application For AVT80, Expanding Proposed Biosimilar Program For Entyvio® To Subcutaneous Presentations 8/31/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration.

  7. Samsung Bioepis Initiates Phase 1 Clinical Trial For SB35, A Biosimilar Candidate Referencing Taltz (Ixekizumab) 8/28/2026

    Samsung Bioepis Co., Ltd. announced today the initiation of Phase 1 clinical trial for SB35, a biosimilar candidate referencing Taltz (ixekizumab)1.

  8. Formosa Pharmaceuticals Files Clinical Trial Application For TSY-110, An Antibody-Drug Conjugate Biosimilar Targeting HER2-Positive Breast Cancers 8/28/2026

    Formosa Pharmaceuticals, Inc. (TWSE: 6838), today announced the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110.

  9. Cancer Biosimilars Associated With Lower Costs For Insurers And Patients, UCLA Study Finds 8/27/2026

    Biologic drugs play an important role in treating cancers such as breast cancer and lymphoma, but their high costs can add to the financial burden of cancer care.

  10. Biosidus Expands Biologics Manufacturing Capacity And Strengthens Global Supply Capabilities For Agalsidase Beta 8/26/2026

    Biosidus, an Argentine biotechnology company with more than four decades of experience in the development and manufacturing of biosimilar medicines, announced that its new bioreactor plant is now operational, increasing the company's biologics production capacity and reinforcing its ability to support potential international demand.