Biosimilar Development News

1. 5 Reasons For Outsourcing Chromatography Resin Lifetime Studies 12/12/2025
2. Is Your Biologics CDMO Transparent? 12/12/2025
3. How To Double Up With A CDMO To Reduce Risk 12/12/2025
4. Biologics CDMO: 3 Qualities Often Overlooked 12/12/2025
5. Biosimilars Forum Calls For Congress To Pass The Skinny Labels, Big Savings Act To Support Safe, Effective And Lower-Cost Biosimilars 12/10/2025

   “The Biosimilars Forum supports the Skinny Labels, Big Savings Act. This bipartisan legislation will promote free-market competition of biosimilars and improve patient access to lower-cost, FDA-approved medications.

6. Polpharma Biologics And Libbs Farmacêutica Sign Licensing Agreement For A Biosimilar For Autoimmune Diseases 12/10/2025

   Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, is thrilled to announce the signing of a landmark licensing agreement with the Brazilian company Libbs Farmacêutica! Through this strategic partnership, Libbs Farmacêutica will gain exclusive rights to commercialize a cutting-edge biosimilar for autoimmune diseases in the rapidly growing Brazilian market.

7. Sandoz Completes Strategic Acquisition Of Just-Evotec Biologics EU SAS, Asserting Biosimilars Leadership 12/8/2025

   Sandoz, the global leader in affordable medicines, today announced the completion of the acquisition of Just-Evotec Biologics EU SAS (JEB SAS) from Evotec SE.

8. Professor Sarfaraz K. Niazi Files Landmark Citizen Petition Urging The FDA To Modernize Biosimilar Approval Pathways And Transform Global Access To Biological Medicines 12/8/2025

   Professor Sarfaraz K. Niazi, Ph.D., a leading authority in pharmaceutical sciences and internationally recognized biosimilars expert, has filed a major Citizen Petition with the U.S. Food and Drug Administration (FDA) calling for sweeping regulatory and scientific reforms that would dramatically reduce the cost, duration, and complexity of biosimilar development—ushering in a new era of global access to life-saving biological drugs.

9. Lupin And Valorum Enter Into An Exclusive Licensing Agreement For Biosimilar Armlupeg (Pegfilgrastim-unne) In The United States 12/4/2025

   Global pharma major Lupin Limited (Lupin) today announced that it has entered into an Exclusive Licensing Agreement with Valorum Biologics (Valorum), a biosimilar specialist in the U.S., for its biosimilar Armlupeg (pegfilgrastim-unne).

10. Mexico Will Receive New Biosimilars For Bone Health Through Saya Biologics In Collaboration With Enzene, A CDMO partner 12/4/2025

    Saya Biologics (“Saya Bio”), a Mexican biopharmaceutical company committed to expanding access to innovative biologic treatments, today announced a strategic partnership with Enzene Biosciences Ltd. (“Enzene”), a global continuously innovative development and manufacturing organization (CDMO), to support Saya Bio’s launch into Mexico of two innovative therapies to target osteoporosis.