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On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sano...

On 26 February 2026, Celltrion reported that it plans to expand its biosimilar lineup to 18 products by 2030 with seven candidates that have either entered clinical development or for which investigational new drug applications are being prepared.  Celltrion’s disclosed pro...

On 25 February 2026, India-headquartered Shilpa Biologics and Costa Rican-based SteinCares announced they have entered into a licensing agreement for commercialisation of an undisclosed biosimilar in Latin America.  

Under the agreement, SteinCares will have exclusiv...

On 25 February 2026, Jiuyuan Genetic Biopharmaceutical announced in a filing with the Hong Kong Stock Exchange that China’s National Medical Products Administration (NMPA) has accepted for review its marketing authorisation application for Jikeqin®, a generic version of Nov...

On 25 February 2026, Formycon and Zydus announced positive results from the phase 1 pharmacokinetic study (“Dahlia”) for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study, commenced in June 2024, is reported to have met its primary objective and demonstrated...

Bayer’s Eylea™ 8mg has received approval in both the UK (reported 25 February 2026) and Korea (reported 27 February 2026) for an expanded indication to include macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.  R...

On 24 February 2026, Sana Pharma announced that Pembrava™, biosimilar to MSD’s Keytruda® (pembrolizumab), has been registered by the Jordan Food and Drug Administration for cancer treatment.  Sana Pharma claims that Pembrava™ is the first biosimilar for cancer treatment in ...

On 24 February 2026, Ono Pharmaceutical announced that the Korean Ministry of Food and Drug Safety has granted additional approval of Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adults with unresectable or metastat...

On 24 February 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.  Dupixent® is the first and only t...