Biosimilar Development News

  1. FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar To NEULASTA® (pegfilgrastim) 7/9/2026

    Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., 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 ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim).

  2. Teva And Polpharma Biologics Announce Global Licensing Agreement For A Biosimilar Candidate To Ocrevus (Ocrelizumab) For Multiple Sclerosis 7/9/2026

    Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd and Polpharma Biologics International AG today announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus1 (ocrelizumab), upon regulatory approval.

  3. First Patient Dosed In China For Phase 1 Clinical Trial Of Henlius' Cetuximab Biosimilar HLX05-N 7/8/2026

    Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in China in the phase 1 clinical trial (HLX05-N-mCRC102) of its independently developed cetuximab biosimilar, HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for the treatment of metastatic colorectal cancer (mCRC).

  4. New Study: States Could Save Up To $1.8B Annually By Prioritizing Lower-Cost Biosimilar Medicines 7/7/2026

    At a time when states across the country are grappling with significant budget challenges, a new study from the Center for Medical Economics and Innovation at the Pacific Research Institute – the nonpartisan, California-based, free market think tank – finds that state employee health plans could save up to $1.8 billion every year by making greater use of lower-cost biosimilars.

  5. Orion And Shilpa Medicare Expand Partnership To Develop And Supply Nivolumab Biosimilar For Europe 7/6/2026

    Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe.

  6. Alvotech Further Strengthens Liquidity By Securing Term Loan Facility Of $75M 7/1/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has amended its existing credit agreement with funds managed by GoldenTree Asset Management LP and other existing lenders of Alvotech to provide a term loan facility of up to $75 million in additional capital.

  7. Harrow Announces Commercial Launch Of BYOOVIZ® In The United States 7/1/2026

    Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the commercial launch of BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab) and developed by Samsung Bioepis Co., Ltd.

  8. Orion Pharma Announces Agreement With Shilpa Medicare For Nivolumab Biosimilar For European Market 6/30/2026

    Orion Pharma (“Orion”) and Shilpa Biologicals Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited (“Shilpa”), have entered into an agreement to commercialise intravenous (iv) nivolumab biosimilar in Europe.

  9. EirGenix Showcases Dual-Track Biosimilars And CDMO Strategy In U.S. Market Push At BIO 2026 6/30/2026

    At BIO 2026, EirGenix presented its comprehensive HER2-positive breast cancer biosimilar portfolio and highlighted its integrated one-stop contract development and manufacturing organization (CDMO) service platform.

  10. Samsung Bioepis Announces Positive Preliminary Phase 1 And Phase 3 Data For SB27, A Proposed Biosimilar To Keytruda (Pembrolizumab) 6/29/2026

    Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to eytruda1 (pembrolizumab), have met their primary endpoints.