Biosimilar Development News

  1. Accord Healthcare Receives Positive CHMP Opinion For Denosumab, Osvyrti®, And Jubereq® 4/2/2025

    Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti® and Jubereq®, across its autoimmune and oncology therapy areas.

  2. Organon Acquires TOFIDENCE (tocilizumab-bavi), A Commercialized Biosimilar To ACTEMRA (tocilizumab) Injection, For Intravenous Infusion In The U.S. 4/1/2025

    Organon, a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. regulatory and commercial rights in the U.S. for TOFIDENCE, a biosimilar to ACTEMRA, for intravenous infusion.

  3. Celltrion's Remdantry, Previously Known As Inflectra, Will Be Available In Canada As Of April 1, 2025 3/28/2025
  4. UK Medicines And Healthcare Products Regulatory Agency Confirms Acceptance Of Marketing Authorization Application For Proposed Biosimilar To Xolair® (omalizumab) 3/28/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion [1].

  5. European Medicines Agency (EMA) Validates Henlius And Organon Filing For Perjeta (pertuzumab) Biosimilar Candidate HLX11 3/28/2025

    Shanghai Henlius Biotech, Inc. (2696.HK) and Organon today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab).

  6. Alvotech Appoints Dr. Balaji V. Prasad As Chief Strategy Officer 3/27/2025

    Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Dr. Balaji V. Prasad as Chief Strategy Officer.

  7. Celltrion's STEQEYMA® (ustekinumab-stba), Now Added To The Costco Member Prescription Program 3/27/2025

    Celltrion, Inc., today announced that STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) has been added to the Costco Member Prescription Program.

  8. Fresenius Receives FDA Approval For Their Denosumab Biosimilars And Secures Global Settlement Agreement 3/27/2025

    Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) of its operating company Fresenius Kabi, has been approved by the U.S. Food and Drug Administration (FDA).

  9. Bio-Thera And Dr. Reddy's Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, And BAT2506, A Proposed Simponi® Biosimilar, For Southeast Asia 3/27/2025

    Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's"), announce today they have reached commercialization and license agreements for BAT2206, a proposed Stelara® biosimilar, and BAT2506, a proposed Simponi® biosimilar.

  10. Biosimilars Forum Executive Director Juliana Reed To Speak At Evolution Of Biosimilars Development Workshop 3/26/2025

    Juliana Reed, executive director of the Biosimilars Forum, will speak at the DIA Evolution of Biosimilar Development Workshop on May 21, 2025. Reed will discuss the current state of the biosimilars industry, highlighting the need for Americans to have increased access to lower-cost biosimilars.