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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 ...

On 1 December 2025, Accord BioPharma announced that Express Scripts has added Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), to its largest commercial formularies, including National Preferred Formulary, starting 5 September 2025.  Express Scripts is one...

On 28 November 2025, Korea Biomedical Review reported that Novartis’ Cosentyx® (secukinumab) will be reimbursed in Korea from 1 December 2025 for adult patients with severe hidradenitis suppurativa who show an inadequate response to standard systemic therapy.

Accordi...

On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November.  Among the new inclusions is an indication extension for MSD’s Keytruda® (pembrolizumab) in combination with paclitaxel a...