Biosimilar Development News

  1. Teva Gains Biosimilar Momentum With U.S. FDA Approval Of PONLIMSI™ (denosumab-adet) And Dual Filing Acceptance For Biosimilar Candidate To Xolair® (omalizumab) 3/30/2026

    Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. 

  2. Shreehas Tambe Appointed CEO & Managing Director Of Biocon Limited, Effective April 1, 2026 3/27/2026

    Biocon Limited today announced the appointment of Shreehas Tambe as its Chief Executive Officer & Managing Director, effective April 1, 2026, following approvals from the Nomination & Remuneration Committee and the Board of Directors.

  3. Neion Bio Emerges From Stealth With Multi-Product Biosimilar Partnership Leveraging Its Cutting-Edge Genetic Engineering Platform 3/26/2026

    Neion Bio, a biotechnology company revolutionizing the production of biologic medicines, today announced its emergence from stealth and the signing of its first co-development and supply agreement with a major global pharmaceutical company.

  4. AEON Biopharma Announces FDA Feedback Following BPD Type 2a Meeting For The ABP-450 Biosimilar Program 3/25/2026

     AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced feedback from the U.S. Food and Drug Administration (“FDA” or the “Agency”) following a successful Biosimilar Biological Product Development (BPD) Type 2a meeting.

  5. Mabwell Established A Licensing And Commercialization Agreement Of Denosumab Biosimilars For Vietnamese Market 3/25/2026

    Mabwell, an innovative biopharmaceutical company with entire industry chain, announced that it has established a licensing and commercialization agreement with a strategic business partner (“the partner”) in Vietnam for its Denosumab biosimilar products MAILISHU (Prolia biosimilar) and MAIWEIJIAN (Xgeva biosimilar).

  6. Health Canada Approves Henlius' BILDYOS (Denosumab Injection) And TUZEMTY (Denosumab Injection), Biosimilars To PROLIA (Denosumab) And XGEVA (Denosumab), Respectively 3/24/2026

    Shanghai Henlius Biotech, Inc. today announced that Health Canada has approved BILDYOS (denosumab) injection 60 mg/mL and TUZEMTY (denosumab, trade name: BILPREVDA in the U.S. and Europe) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference product.

  7. Celltrion Announces KRW 1.2T Expansion Of New DS Production Facilities In Songdo; Adds 180,000L Of DS Capacity, Bringing Total Capacity To 570,000L 3/24/2026

    Celltrion announced today that it plans to secure additional manufacturing capacity through a large-scale expansion investment exceeding KRW 1 trillion at its Songdo headquarters to respond to rapidly increasing global demand for its biologics portfolio and further strengthen its global manufacturing competitiveness.

  8. Prestige Biopharma Announces Positive Topline Results From Comparative SAMSON-II Study For HD204, A Potential Biosimilar To Avastin (bevacizumab) 3/23/2026

    Prestige Biopharma today announced positive topline results from its Phase 3 SAMSON-II study evaluating HD204, a proposed biosimilar to Avastin® (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).

  9. Bio-Thera Solutions Announces Further Expansion Of Partnership With Intas Pharmaceuticals For BAT2506, A Proposed Biosimilar Referencing Simponi® (golimumab), Through Exclusive Commercialization And License Agreement In India 3/23/2026

    Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced a further expansion of its partnership with Intas Pharmaceuticals for BAT2506, a proposed golimumab biosimilar, through an exclusive commercialization and license agreement for India.

  10. Cytiva And Yoshindo Advance Domestic Biosimilar Manufacturing In Japan Through FlexFactory Collaboration 3/23/2026

    Cytiva, a Danaher company and a leader in the life sciences industry, today announced that it has signed a FlexFactory contract with Yoshindo, supporting the company’s plans to establish domestic biosimilar drug substances manufacturing capabilities for the Japanese market.