Biosimilar Development News

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

9. US Food And Drug Administration (FDA) Approves Henlius And Organon's BILDYOS (denosumab-nxxp) And BILPREVDA (denosumab-nxxp), Biosimilars To PROLIA (denosumab) And XGEVA (denosumab), Respectively 9/2/2025

   Shanghai Henlius Biotech, Inc. (2696.HK), and Organon today announced the US Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.^1,2

10. Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance To Waive Clinical Efficacy Studies For Monoclonal Antibody Biosimilars 9/1/2025

    In a groundbreaking milestone for global healthcare and pharmaceutical innovation, Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago and founder of multiple biopharmaceutical enterprises, has secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars.