Biosimilar Development News

  1. Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch In Japan 5/19/2026

    Samsung Bioepis Co., Ltd. today announced the launch of Ustekinumab BS 45 mg Syringe for S.C. Injection「 NIPRO」, a biosimilar referencing Stelara1 (ustekinumab), marking its first product launch in Japan under partnership with NIPRO CORPORATION (hereafter “NIPRO”).

  2. FDA Approves IMMGOLIS™ (golimumab-sldi) And IMMGOLIS INTRI™ (golimumab-sldi), First Biosimilars To Simponi® (golimumab) And Simponi Aria® (golimumab); Accord BioPharma To Lead U.S. Commercialization 5/18/2026

    Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, and adult patients with moderately to severely active ulcerative colitis (UC).

  3. MS Pharma Announces Strategic Growth Investment From Olayan Financing Company 5/18/2026

    MS Pharma today announced that Olayan Financing Company (OFC) has made a minority equity investment in the company.

  4. Sandoz Confirms European Commission Approval For Biosimilars Bysumlog (Insulin Lispro) And Dazparda (Insulin Aspart), Strengthening Position In Diabetes 5/15/2026

    Sandoz, the global leader in affordable medicines, today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals.

  5. Alteogen Receives MFDS Approval For Aflibercept Biosimilar, EYZANFY (ALT-L9) 5/15/2026

    Alteogen Inc. announced today that it has received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for EYZANFY (aflibercept, code name: ALT-L9), a biosimilar to Eylea.

  6. Federal Budget 2026-27: Biosimilars Recognised As An Opportunity To Expand Patient Access 5/13/2026

    The 2026-27 Federal Budget marks a significant milestone in efforts to expand access to biologic medicines.

  7. IQVIA And Kexing Biopharm Expand Strategic Collaboration To Accelerate Global Biosimilar Development Using AI-Enabled Capabilities 5/13/2026

    IQVIA a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, is advancing its strategic collaboration with Kexing Biopharm to support a global, multi-product biosimilar development and commercialization program.

  8. Globalisation 2.0 | U.S. FDA Clearance Of IND For Cetuximab Biosimilar HLX05-N 5/10/2026

    On May 10, 2026, Shanghai Henlius Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for HLX05-N, Henlius' self-developed biosimilar of cetuximab (The recombinant anti-EGFR human/murine chimeric monoclonal antibody), for the treatment of metastatic colorectal cancer (mCRC).

  9. Xbrane And Its Partner Intas Agree On Revised Financing Arrangement For Xbrane's Xdivane Development Activities 5/5/2026

    Xbrane Biopharma AB (publ) (“Xbrane” or the “Company”) is co-developing Xdivane (Opdivo biosimilar candidate) together with its partner Intas Pharmaceuticals Ltd. (“Intas”).

  10. CVS Caremark Expands Biosimilar Adoption Through Formulary Updates To Improve Affordability And Access 5/5/2026

    CVS Health (NYSE: CVS) today announced updates to its most common commercial template formularies that will expand the use of lower-cost biosimilars across multiple therapeutic categories, including changes effective July 1, 2026, that will prefer interchangeable biosimilars over select reference brands.