Biosimilar Development News

  1. Alvotech Announces Resubmission Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria®, And AVT06, A Proposed Biosimilar To Eylea® 6/4/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the resubmission to the U.S. Food and Drug Administration (FDA) of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab), and AVT06, a proposed biosimilar to Eylea® (aflibercept) 2 mg.

  2. AEON Biopharma To Present Data Demonstrating Structural And Functional Comparability Of ABP-450 To BOTOX® At The 68th Annual Scientific Meeting Of The American Headache Society 6/4/2026

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced the presentation of new analytical and functional data supporting biosimilarity of ABP-450 to BOTOX® at the 68th Annual Scientific Meeting of the American Headache Society (“AHS”), being held June 4-7, 2026 in Orlando, Florida. 

  3. Lupin Receives Approval From U.S. FDA For Ranluspec™ (ranibizumab) Injection 6/4/2026

    Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing to Lucentis® (Genentech).

  4. Teva Expands European Biosimilars Portfolio With Launch Of AHZANTIVE® (aflibercept) Biosimilar To Eylea® 6/4/2026

    Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of AHZANTIVE (aflibercept), a biosimilar to Eylea®, in Europe further strengthening the Company’s growing biosimilars portfolio and expanding its presence in ophthalmology.

  5. Chime Biologics And Daewoong Pharmaceutical Enter Strategic Partnership To Advance Dupilumab Biosimilar Development And Commercialization In Global Markets 6/2/2026

    Chime Biologics, a global biologics CDMO dedicated to enabling partners’ success, and Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, today announced the signing of a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Dupixent.

  6. USP Publishes Product-Specific Emerging Biologics Standards For Public Comment 6/1/2026

    The U.S. Pharmacopeia (USP) today announced the publication of a set of product-specific biologics emerging standards, now available for public comment through the Emerging Standards Platform.

  7. Henlius' Pertuzumab Approved In China, Solidifying Breast Cancer Strategy As The First China-US-EU Approved Chinese Trastuzumab-Pertuzumab Combination 5/29/2026

    Henlius announced that the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY) has been approved by the National Medical Products Administration (NMPA).

  8. Boan Biotech Submits A Biologics License Application For Two Denosumab Biosimilars In The U.S. 5/29/2026

    Boan Biotech announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its two biosimilars: BA6101 (denosumab injection 60 mg) and BA1102 (denosumab injection 120 mg). This submission marks a milestone in the company’s efforts to accelerate the global expansion of its core products.

  9. A580 - Multiple Sclerosis Medication: The Italian Competition Authority Launches Investigation Into Biogen 5/27/2026

    Authority concerned that the Biogen group may have pursued a strategy designed to exclude and limit competition from Sandoz, a new entrant, in the market for drugs treating multiple sclerosis containing natalizumab.

  10. Globalisation 2.0 | First Patient Dosed In China For International Multi-Centre Phase 1 Clinical Trial Of Henlius' Subcutaneous Daratumumab Biosimilar HLX15-SC 5/26/2026

    Shanghai Henlius Biotech, Inc. today announced that the first patient in China has been dosed in the international multi-centre Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM).