EMA seeks input on draft revisions to biosimilar efficacy guidance

The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies.

The changes are intended to clarify the data needed to demonstrate similarity of biological medicines, which could affect how sponsors design and run biosimilar trials across Europe.

A recent JAMA Network Open analysis showed that almost nine out of ten FDA‑approved drugs with post‑marketing study requirements have fulfilled them, with most results posted publicly, highlighting the role of transparent post‑marketing data in regulatory oversight.