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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...

On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in major parts of the Asia-Pacific regi...

In an effort to “champion equitable access to medicine” Brazil and India have entered into a series of agreements to support Brazilian domestic manufacture of publicly funded oncology medicines.

On 21 February 2026, it was announced at the India-Brazil Business Forum...

During its Q3 FY26 Earnings Call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab biosimilar and may potentially be first to launch in the US, subject to regulatory appr...