Biosimilar Development News

1. Waltz Health And Fresenius Kabi Expand Direct Access To Biosimilars Through Waltz Connect Platform 10/29/2026

   Waltz Health®, an EVERSANA® company developing technologies and services that support better-informed decisions on prescription care and Fresenius Kabi®, an operating company of Fresenius, and a leading provider of essential medicines and medical technologies, today announced an agreement to provide employers, payers and pharmacy benefit managers (PBMs) with direct access to three competitively priced biosimilars.

2. Generic Medicines Manufacturers Ramp Up Patch Supply To Meet Demand 10/14/2026

   The Association for Accessible Medicines and the Biosimilars Council today highlighted the key role generic medicines manufacturers, led by several AAM member companies, are playing in ramping up the supply of estrogen patches as demand has dramatically increased.

3. Formycon And Zydus: FYB206 Becomes First Publicly Announced Keytruda Biosimilar Accepted For Review By FDA 10/13/2026

   Formycon, an independent developer of biosimilars, and Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, jointly announce that the US Food and Drug Administration (“FDA”) has accepted for review the Biologics License Application (“BLA”) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab).

4. Xbrane Announces Full Recruitment Of Pivotal Clinical Trial For Xdivane 10/13/2026

   Xbrane Biopharma AB (publ) ("Xbrane" or the "Company"), a biotechnology company specializing in biosimilars, today announced that the pivotal clinical trial for Xdivane, the Company’s biosimilar candidate to Opdivo (nivolumab), has achieved full patient recruitment.

5. Accord BioPharma Launches FILKRI™ (filgrastim-laha); Now Offers Both Long- And Short-Acting G-CSF Options 10/12/2026

   Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim).

6. Thyme Companies Launches First New Venture, Thyme Therapeutics, To Build A More Sustainable, Lower-Cost Oncology Biosimilar Model 10/8/2026

   Thyme Companies, a family of businesses purpose-built to solve problems across the cancer care landscape, today announced the launch of Thyme Therapeutics, a new business focused on driving reductions in the cost of oncology drugs.

7. LOTTE Biologics And Alvotech Announce US-Based Manufacturing Agreement To Increase Global Supply 10/8/2026

   LOTTE Biologics, a contract development and manufacturing (CDMO) organization, and Alvotech, a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today a long-term strategic manufacturing partnership.

8. Kamada Announces Expansion Of Biosimilars Portfolio With The Launch Of Two Additional Products In Israel 10/6/2026

   Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced the expansion of its biosimilar portfolio with the commercial launch of two additional new products in Israel, adding to its existing portfolio of two products.

9. Orion Pharma Announces Agreement With Qilu Pharma Europe For Pembrolizumab Biosimilar For European Market 10/6/2026

   Orion Corporation (“Orion Pharma”) and Qilu Pharma Europe (“Qilu”) have entered into an agreement to commercialise intravenous (IV) pembrolizumab biosimilar in Europe. Pembrolizumab is an immune checkpoint inhibitor which is used to treat various cancers. Qilu is currently developing IV pembrolizumab.

10. Formycon Optimizes Biosimilar Development With AI-Powered Technologies: Digital Solutions Enhance Development Efficiency As Part Of The FYB4GROWTH Strategy 10/6/2026

    Formycon AG is enhancing the efficiency and scalability of its biosimilar development activities through the focused use of digital technologies.