The European Medicines Agency's human medicines committee has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Italy’s Olon has announced a €10m investment in a new R&D hub in Rodano, Milan, that the active pharmaceutical ingredient specialist says will help to consolidate its expertise and connect its worldwide network of 11 facilities.

French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.

Japan’s Nichi-Iko has formally entered a business turnaround alternative dispute resolution process that will see the company outline a business rehabilitation plan involving management restructuring and a fresh profit structure, following financial underperformance in the wake of recent quality issues.

Alvotech has announced success in its confirmatory clinical safety and efficacy study for its AVT04 ustekinumab candidate, a proposed biosimilar to Stelara.