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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.

Under the agreement, Formyc...

On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology.  According to Celltrion, its SC technology involves temporarily decomposing hyaluronic acid pr...

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.

The two companies have prev...

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.

Under the proposed transaction, Biocon Limited wil...

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), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)...

On 4 December 2025, Formycon and MS Pharma 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 MENA region.

Under the agreement, Formycon will rece...

On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous) presentations, making Avtozma® the first tocilizumab biosimilar approved in New Zealand.

On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form.  Just days later, on 4 December 2025, Lupin also announced that it entered into an exclusive licensing a...

On 4 December 2025, Halozyme announced that the Munich Regional Court has granted its application for a preliminary injunction to prevent MSD from distributing and offering for sale in Germany its Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph).  The decision w...