UK Promises Reduced Trial Burden For Biosimilars

MHRA Sets Out Plans For ‘Innovative’ Procedure After EU Transition

New UK licensing procedures for biosimilars are about to be set out by the MHRA that will reduce the clinical trial data burden for applicants.

Heavy box
The MHRA is planning to reduce the trial burden for biosimilars • Source: Shutterstock

A “new innovative UK licensing procedure for biosimilar products” is set to be unveiled by the country’s Medicines and Healthcare Products Regulatory Agency by the end of September that will come into force from 1 January 2021 and will “reduce the burden on clinical trial data generation” for applicants.

Currently, all marketing authorization applications for UK biosimilars are handled centrally by the European Medicines Agency. However, the announcement by...

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