Biosimilar Development News

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. Formycon Secures License Date For Aflibercept 2 mg Biosimilar FYB203 In Europe And Further Territories Following Settlement With Regeneron And Bayer 3/19/2026

    Formycon AG (“Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea1 2 mg biosimilars AHZANTIVE2 and Baiama3.

  7. Biopharma SHAKTI Scheme 3/17/2026

    With a view to strengthen the domestic biopharmaceutical sector and enhance global competitiveness in biologics and biosimilars, the Government has announced the Biopharma SHAKTI scheme with an outlay of ₹10,000 crore over five years with an objective to build a globally competitive domestic ecosystem for biologics and biosimilars to support affordable healthcare in India and enable India to emerge as a global biopharma manufacturing and innovation hub.

  8. Celltrion Announces U.S. Availability Of AVTOZMA® (tocilizumab-anoh) Subcutaneous (SC) Formulation 3/16/2026

    Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation is now commercially available to patients in the United States.

  9. 3PBIOVIAN And INC Partner To Expand Access To Oncology Treatments In Colombia Through Biosimilar Development 3/13/2026

    3PBIOVIAN, a leading Contract Development and Manufacturing Organization (CDMO), and the National Cancer Institute (Instituto Nacional de Cancerología) in Colombia (INC) has signed a contract to carry out the development of a biosimilar monoclonal antibody (mAb) for an oncology indication, marking the first biosimilar mAb to be developed specifically for expanding access to oncology treatments in Colombia.

  10. Celltrion Set To Benefit From Global Biosimilar Regulatory Streamlining, Driving Economies Of Scale From Development To Manufacturing And Direct Sales 3/13/2026

    Celltrion announced today that it will immediately incorporate newly announced global regulatory updates aimed at streamlining biosimilar development into its ongoing pipeline programs, with the goal of significantly reducing development costs and timelines.