Biosimilar Development News

  1. AAM Applauds Momentum As Two Bills Move Through Senate HELP Committee 6/17/2026

    Today, alongside its Biosimilars Council, the Association for Accessible Medicines applauds the positive momentum for America’s patients, as the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act both pass out of the Senate HELP Committee.

  2. Sandoz Steps Up In-House Biosimilar Capabilities, Opening State-Of-The-Art Development Centre To Capture 'Golden Decade' Opportunity 6/17/2026

    Sandoz, the global leader in affordable medicines, today inaugurates a new biosimilar development centre in Ljubljana,

  3. Alvotech Announces FDA Acceptance Of Biologics License Application For AVT16, A Proposed Interchangeable Biosimilar To Entyvio® 6/16/2026

    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 AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

  4. Xbrane Biopharma AB And JOINN Biologics US Inc. Enter Strategic Partnership To Develop Xdarzane – Xbrane´s Biosimilar Candidate To Darzalex (Daratumumab) 6/11/2026

    Xbrane Biopharma AB (“Xbrane”), a Sweden-based biotechnology company focused on the development of biosimilars, and JOINN Biologics US Inc. (“JOINN”), a US-based leading biologics development and manufacturing organization, today announced that the companies have entered into a strategic partnership featuring customized development services for Xdarzane, Xbrane´s biosimilar candidate referencing Darzalex (daratumumab).

  5. Abbott Receives Approval For Two New Biosimilars In Brazil, Expanding Access To Treatment For Osteoporosis And Bone Complications Related To Cancer 6/11/2026

    Abbott (NYSE: ABT), a global leader in healthcare, has just received regulatory approval from Anvisa (Brazilian Health Regulatory Agency) for two new denosumab biosimilar medications in Brazil (60 mg and 120 mg), representing another significant step in expanding access to advanced therapies for osteoporosis and cancer-related bone complications.

  6. GlycoNex Announces Positive Topline Results For Phase III Clinical Trial Of Denosumab Biosimilar SPD8 6/10/2026

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, has successfully met its primary endpoint.

  7. Bio Techne And Refeyn Close Critical Gap In Bispecific Antibody And Biosimilar Characterization 6/4/2026

    Bio‑Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents and diagnostic products, and Refeyn, the pioneer in mass photometry technology, today announced a first‑of‑its‑kind integrated workflow for the characterization of charge and size variants in bispecific antibodies and biosimilars.

  8. 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.

  9. 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. 

  10. 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).