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On 5 February 2026, Korea Biomedical Review reported that Korean headquartered HK inno.N has received approval from Korea’s Ministry of Food and Drug Safety for Izambia Prefilled Syringe and Denbrayce Injection, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

On 5 February 2026, Alvotech announced positive results from a pharmacokinetic study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab).

The Phase 1 study evaluated the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Enty...

On 4 February 2026, Mexican-headquartered Saya Biologics announced that it has entered a strategic collaboration agreement with Kashiv BioSciences for commercialisation of an undisclosed supportive biosimilar oncology therapy in Mexico and the Central America and Caribbean ...

On 4 February 2026, R-Pharm announced it has obtained Russian marketing authorisation for the anti-cancer drug Arcetux™, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab).  This is the first biosimilar cetuximab to be approved in Russia.

Arcetux™ has been app...

On 3 February 2026, Bio-Thera Solutions and Saudi-based Avalon Pharma announced that they have entered commercialisation and licence agreements for Bio-Thera’s BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in Saudi Arabia and MENA.

Under the agreement, Aval...

On 3 February 2026, Amgen announced its financial results for Q4/2025 and full year 2025, including providing the following update on its biosimilar pipeline:

Nivolumab: Amgen has completed enrolment in a comparative clinical study comparing ABP 206 (nivolumab) wit...