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UK’s MHRA finalises biosimilar guidance

May 12, 2021

The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products‘, outlining the licensing requirements for biosimilars in the post-Brexit UK.  The MHRA had previously foreshadowed in its draft guidance that comparative efficacy/safety trials would not be necessary for most biosimilars.  The MHRA has maintained its position in this finalised guidance, stating that ‘Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.‘.