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A final question-and-answer guidance tells biosimilar makers what data to file when they change how an approved product is made, fulfilling a 2022 user-fee commitment. It was issued on 13 October 2026.
A hybrid public meeting on 26 October will discuss proposed BsUFA IV recommendations. The fees that fund FDA review of biosimilar applications expire in September 2027 and need new legislation to continue.
The 2012 safe harbour for 3Rs data was barely used. The replacement is a voluntary pilot that takes submissions independently of a marketing application, running until the third quarter of 2027.
The CHMP's June meeting recommended pulling avacopan from the EU market on data-integrity grounds, refused three cell and biological therapies, and reversed itself on a Rett syndrome drug it had earlier rejected.
Anvisa's five new resolutions build a controlled supply chain from seed to shelf, including a regulatory sandbox for patient associations. Analysts say the framework's biggest gap is the one it did not close.