Biosimilar Development News

  1. Mabwell Announces NMPA Approval Of Supplemental Application For Additional Indications Of MAIWEIJIAN (Denosumab Injection) 5/21/2026

    Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk of skeletal-related events (pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery)) .

  2. Dr. Reddy's Laboratories Announces Launch Of Oral Semaglutide Biosimilar 'Obeda' (Tablets) In India 5/20/2026

    Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, today announced the launch of its oral semaglutide biosimilar, indicated for type 2 diabetes mellitus.

  3. Formycon Expands Commercial Portfolio: Aflibercept Biosimilars Ahzantive And Baiama Are Now Available In The European Union 5/19/2026

    Formycon AG and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce the launch of the Eylea1 2mg biosimilar FYB203 in the European Union.

  4. 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”).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.