Pfizer appears to be maintaining its “opportunistic” approach to biosimilars, having ceased to split out the business unit’s results during its Q3 earnings report.

Prestige says a meeting with the FDA in November represents a “final step” before filing its trastuzumab biosimilar with the US agency by the end of the year. Meanwhile, a major shareholder has invested further in the Singapore-based biosimilars developer.

The European Medicines Agency has delivered its verdict on marketing applications for a raft of new medicines.

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.