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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...

On 3 December 2025, Fresenius Kabi announced that the FDA has accepted for review Sam Chun Dang’s (SCD) application for its biosimilar aflibercept, SCD411.  Under a December 2024 licensing agreement between Fresenius Kabi and SCD, Fresenius has the exclusive rights to comme...

On 3 December 2025, Celltrion announced that it received FDA approval for a new 300 mg/2 mL pre-filled syringe presentation of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  The US approval follows EU approval of the same dosage form in November 2025.

Omlyc...

On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s Prolia® and Xgeva®.

Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (...

Regeneron/Bayer and Sandoz have settled Australian aflibercept patent infringement/revocation proceedings, with the Federal Court of Australia on 27 November 2025 dismissing all related proceedings by consent (VID715/2025; VID968/2025; VID1234/2025).  The terms of the AU se...

On 2 December 2025, Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Byooviz® pre-filled syringe (PFS), biosimilar to Genentech’s Lucentis® (ranibizumab).

The positive CHM...