MHRA Guidance on the Licensing of Biosimilar Products

On 7 October 2020 the MHRA published the open consultation document.

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

Applicants should also consider the principles contained within the Committee for Medicinal Products for Human Use (CHMP) guidelines. This UK guidance contains some revisions to these CHMP guidance documents, to be implemented at the end of the transition period (1 January 2021).

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