UK – Guidance on the licensing of biosimilar products

This guideline is to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.

The purpose of this guideline is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in Northern Ireland/Great Britain/UK.

Applicants should also take into account principles contained within the Committee for Medicinal Products for Human Use (CHMP) guidelines…