Tagged as: MHRA

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…

Read More