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Dec 13, 2025
On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in Europe and ROW…
Dec 12, 2025
On 12 December 2025, Celltrion announced that it had successfully secured reimbursement coverage for Avtozma® IV, biosimilar to Roche’s Actemra® (tocilizumab), in the US, having signed a listing agreement with Synergie Collective…
Dec 12, 2025
On 12 December 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its December 2025 meeting, including positive opinions for two biosimilars.
Dec 12, 2025
At its December 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for a number of biopharmaceuticals. Among these, Regeneron/Bayer’s…
Dec 11, 2025
On 11 December 2025, Bristol Myers Squibb announced that the FDA has granted priority review to its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine chemotherapy…
Dec 10, 2025
On 10 December 2025, Polpharma Biologics announced that it has entered a licence agreement with Brazilian pharmaceutical company, Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.
Dec 10, 2025
On 10 December 2025, Zydus Lifesciences announced the Indian launch of Zyrifa™ (denosumab 120mg SC), biosimilar to Amgen’s Xgeva® (denosumab).
Dec 9, 2025
On 9 December 2025, Formycon and Zydus Lifesciences announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.
Dec 8, 2025
On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology.
Dec 8, 2025
On 8 December 2025, GxP News reported that Russia’s Binnopharm Group and China’s Mabwell have signed a MOU in relation to localising the production of Mabwell’s biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab) in Russia and the EAEU.
Dec 6, 2025
On 6 December 2025, Biocon Limited announced that Biocon Biologics will be integrated into it, becoming a wholly owned subsidiary of the company upon completion of the transaction, expected to occur by 31 March 2026.
Dec 5, 2025
On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15)…
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