Biosimilars

Sandoz’s aflibercept biosimilar Enzeevu launch in Canada comes just a few days after the firm signed a multiple asset deal, including an undisclosed ophthalmology product, with Alvotech, which recently gained immediate launch for its Eylea rival in the country.

After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.

Positive results from a randomized study in healthy volunteers mark a key milestone for Alvotech’s proposed Entyvio rivals AVT80 and AVT16.

A biosimilar collaboration between Kashiv and Saya aims to expand access to affordable supportive oncology therapies in Mexico and 10 additional Central America and Caribbean markets.

Amgen has revealed just how significant its first-mover advantage on biosimilar aflibercept has been in the US, with the firm’s Eylea rival bringing in sales of $700m in 2025 and helping to push Amgen’s annual biosimilars turnover up by more than a third to $3bn.

BC Partners has completed its acquisition from Servier of French generics giant Biogaran after the French government allowed the private-equity takeover on condition that BPI France take a minority stake. Meanwhile, former Biogaran CEO Erick Roche has returned to the role after a long stint at Teva.

Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.

Sandoz and Alvotech have struck a deal that will see the firms collaborate on multiple biosimilar candidates for the Australian, Canadian and New Zealand markets across therapeutic areas including ophthalmology, immunology and gastroenterology.

The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.

Generics Bulletin previews the most noteworthy and anticipated events for February 2026.

Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.

Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.