Blog Big Molecule Watch November 17, 2022

The UK’s MHRA Updates its Guidance on Licensing of Biosimilars

On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a biosimilar and reference medicinal product (“RP”).  The UK’s Guidance now recognizes that “[o]nce authorised, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect. Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.”  The Guidance further explains that “[a]s a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice.”

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