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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...

On 2 December 2025, Celltrion announced that it has launched Remsima® SC (infliximab) in Chile, marking the biosimilar’s first entrance into the public market in Central and South America.

Remsima® SC was first listed on the Chilean public insurance plan in April 202...

On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), in Europe from 2 December 2025.  The settlement foll...

On 1 and 2 December 2025, European launches of denosumab biosimilars were announced by the following sponsors:

Fresenius Kabi announced the 1 December launch of Conexxence® and Bomyntra® (EU approved in July 2025), biosimilars to Amgen’s Prolia® and Xgeva® respecti...

On 1 December 2025, Celltrion announced that it has signed a formulary listing contract with one of three undisclosed “major” US pharmacy benefit managers (PBM) for its denosumab biosimilars, Stoboclo® and Osenvelt®, referencing Amgen’s Prolia® and Xgeva®, respectively.

On 1 December 2025, Sandoz announced the EU launch of Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  Jubbonti® and Wyost® were approved for all reference indications by the European Commission (EC) in May 2024, and are the first ...