Biosimilar Development News

  1. Horus Pharma Becomes Additional Commercialization Partner For Formycon's Eylea Biosimilar FYB203 In Selected European Countries Under The Brand Name Baiama 9/17/2025

    Formycon AG announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), concluded an additional semi-exclusive license agreement with Horus Pharma (“Horus”) for the commercialization of FYB203/Baiama2 in selected European countries.

  2. Alteogen Receives European Commission Approval For Aflibercept Biosimilar, EYLUXVI® (ALT-L9) 9/17/2025

    Alteogen Inc. (KOSDAQ:196170) announced today that the European Commission (EC) has granted marketing authorization for EYLUXVI® (code name: ALT-L9), an Eylea® biosimilar co-developed by its subsidiary, Alteogen Biologics.

  3. Bio-Thera Strikes Strategic Deal With Jamjoom Pharma For Securing Cosentyx Biosimilar In MENA 9/15/2025

    Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars and Jamjoom Pharmaceuticals Factory Company (Jamjoom Pharma), one of the fastest-growing pharmaceutical companies in the Middle East and Africa, announced the signing of a strategic commercialization agreement for BAT2306, a biosimilar referencing Cosentyx.

  4. Kashiv BioSciences And CRISTÁLIA Enter Into Licensing And Supply Agreement For Omalizumab Biosimilar (ADL-018) In Latin America 9/11/2025

    Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into a licensing and supply agreement with CRISTÁLIA, one of the leading pharmaceutical companies in Brazil, for the commercialization of ADL-018 / bOmalizumab, a proposed biosimilar to Xolair, in Latin America (LATAM).

  5. Medicines And Healthcare Products Regulatory Agency (MHRA) Approves Bio-Thera Solutions' Qletli (adalimumab), A Biosimilar Referencing Humira 9/10/2025

    Bio-Thera Solutions Inc. , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the MHRA has approved Qletli (adalimumab), a biosimilar of Humira, for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, crohn’s disease, ulcerative colitis, uveitis in adults, and polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis and uveitis in paediatric.

  6. Sandoz Reaches Agreement With Regeneron, Resolving All Patent Litigation Related To Its US Aflibercept Biosimilar 9/9/2025

    Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc. (Regeneron), to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz aflibercept biosimilar.

  7. Fresenius Receives A €400M EIB Loan To Support R&D, Innovation And Capacity Expansion Across The EU 9/8/2025

    Fresenius, a global healthcare company, will receive a new €400M loan from the European Investment Bank (EIB) to strengthen Fresenius’ European research and development (R&D) activities.

  8. Mabwell Secures Pakistan's First Denosumab Injection Approval 9/5/2025

    Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, hereinafter "Searle") jointly announced that two denosumab products, 9MW0311 and 9MW0321, have received marketing authorization from Drug Regulatory Authority of Pakistan (DRAP).

  9. Polpharma Biologics And MS Pharma Sign Licensing Agreements For Proposed Vedolizumab (PB016), Ocrelizumab (PB018) And Guselkumab (PB019) Biosimilars 9/2/2025

    Polpharma Biologics S.A. (“Polpharma Biologics”), specialized in the development and manufacturing of biosimilars, today announced that it has signed licensing agreements with MS Pharma, a leading biosimilar production and distribution company in the Middle East and North Africa (MENA) region, for the commercialization of its biosimilar candidates vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) in the MENA region.

  10. Alex Keeton Named Head Of The Biosimilars Council, Senior Vice President Of Policy 9/2/2025

    The Association for Accessible Medicines today welcomes Alex Keeton as the Executive Director of the Biosimilars Council and Senior Vice President of Policy for AAM.