MHRA Guidance on the Licensing of Biosimilar Products

On 6 May 2021 the UK MHRA published the guidance on the licensing of biosimilar products.

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.

This MHRA guidance contains further clarifications and some revisions to these CHMP guidance documents, which take into account the scientific and regulatory experience gained since the first biosimilar product was licensed in 2006, including biosimilar monoclonal antibodies and fusion proteins licenced from 2013.

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