Biosimilar Development News

  1. OMLYCLO® (omalizumab-igec), The First And Only FDA-Approved Interchangeable Biosimilar To XOLAIR®, Now Commercially Available In The U.S. 10/5/2026

    Celltrion USA, Inc. today announced the availability of OMLYCLO® (omalizumab-igec), the first and only U.S. Food and Drug Administration (FDA) approved interchangeable biosimilar to XOLAIR® (omalizumab). OMLYCLO® is now available in 75 mg/0.5 mL, 150 mg/mL and 300mg/2mL in a single-dose prefilled syringe for subcutaneous injection.

  2. The Biosimilars Forum Commends Governor Newsom For Signing Landmark Biosimilars Legislation Into Law 10/2/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after California Gov. Gavin Newsom signed SB 1094, authored by State Sen. Akilah Weber Pierson (D-San Diego), into law.

  3. Samsung Bioepis And Teva Expand Strategic Partnership To Advance Up To Six Potential Biosimilar Candidates 10/1/2026

    Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. today announced that the companies have entered into a global license, development, and commercialization agreement for up to six potential biosimilar candidates, with two confirmed investigational biosimilar candidates, SB41, a biosimilar candidate referencing Fasenra1 (benralizumab), and SB44, a biosimilar candidate referencing Ilaris2 (canakinumab).

  4. Fresenius Completes Acquisition Of mAbxience, Creating A Stronger Platform For Future Portfolio Expansion 10/1/2026

    mAbxience today announced that Fresenius SE & Co. KGaA has acquired the remaining 45% of mAbxience from Insud Pharma, building on the successful partnership established between the two companies in 2022 and marking the beginning of a new phase of growth for the company.

  5. The Biosimilars Forum Welcomes Bipartisan Legislation To Strengthen Biosimilar Competition 9/30/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after bipartisan legislation (H.R.10628 and S.5571) was introduced in the House of Representatives and the Senate that would help strengthen biosimilar competition and lower costs for prescription drugs.

  6. AEON Biopharma FDA Type 2b Meeting Feedback Clarifies Biosimilar Development Plan For ABP-450 9/30/2026

    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 receipt of the official minutes from its Biosimilar Biological Product Development (“BPD”) Type 2b meeting held with the U.S. Food and Drug Administration (“FDA” or the “Agency”) regarding ABP-450’s development pathway.

  7. The Biosimilars Forum Strongly Supports FDA's BsUFA IV Agreement To Strengthen Biosimilar Development And Review 9/29/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement supporting the U.S. Food and Drug Administration’s release of the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter.

  8. Sandoz Opens Advanced High-Volume Drug Substance Manufacturing Centre In Lendava, Significantly Strengthening In-House Capacity And Flexibility Across Leading European Biosimilar Network 9/29/2026

    Sandoz, the global leader in affordable medicines, today opens a high-tech, high-volume biosimilar drug substance production centre in Lendava, Slovenia.

  9. STADA And SBP Group Launch Strategic Biosimilars Partnership, Including A Biosimilar To Keytruda 9/28/2026

    STADA Arzneimittel AG, a leading healthcare and pharmaceuticals company specializing in Consumer Healthcare, Generics and Specialty pharmaceuticals, and China-based multinational pharma group SBP Group, through its core innovative pharmaceutical subsidiary CTTQ, today announced a strategic biosimilars partnership designed to significantly broaden patient access to high‑value biological medicines in key markets.

  10. Meitheal Pharmaceuticals Announces FDA Approval Of High-Concentration Formulation Of YUSIMRY, A Biosimilar To Humira 9/28/2026

    Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced that the U.S. Food and Drug Administration (“FDA”) has approved a high-concentration formulation (“HCF”) for YUSIMRY (adalimumab-aqvh), as an interchangeable biosimilar to Humira.