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On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab).  According to the announcement, plans are underway to launch Gotenfia® in Europe “in th...

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

In Apri...

On 12 February 2026, Pharmacy Daily announced that Arrotex Pharmaceuticals and Pfizer Australia have entered into a commercial partnership for Enbrel® (etanercept) in Australia.  Under the agreement, Arrotex will be responsible for representing Pfizer’s Enbrel® across Austr...

On 12 February 2026, Zhitong Finance reported that Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration (NMPA) for a Phase 1 trial of its subcutaneous daratumumab biosimilar, HLX15-SC.

This follows Henlius’ completion o...

On 12 February 2026, Samsung Bioepis announced that it has entered a settlement and licence agreement with Regeneron in relation to commercialisation of Opuviz™ (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), in the US.  Under the terms of the agreement, Samsung Bio...

On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency (EMA) to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).  Celltrion expects this approval ...

On 11 February 2026, the Supreme Court of India dismissed the Special Leave Petition of BMS requesting an appeal from the decision of the High Court of Delhi appellate division that allowed Zydus to launch its low cost nivolumab biosimilar, Tishtha®, pending resolution of t...