A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Alvotech has announced its latest European biosimilars partnership, collaborating with Advanz on both 2mg and 8mg aflibercept rivals to Eylea. The deal follows several other recent alliances as well as a raise in Alvotech’s full-year revenues guidance to as much as $500m.

With originator Xolair’s patents already expired or about to end next year, Aurobindo’s CuraTeQ is on track with its omalizumab biosimilar for regulatory filings in 2024/2025, following a Phase I trial completion.