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UK Promises Reduced Trial Burden For Biosimilars

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

Executive Summary

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.

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UK Lays Out Reduced Data Pathway For Biosimilars

The UK drug regulator, the MHRA, has laid out its plans for a biosimilar licensing pathway that will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications. The local biosimilars industry believes the guideline creates an opportunity for the UK to be the first launch market for its products.

UK Lays Out Reduced-Data Pathway For Biosimilars

The UK’s MHRA has laid out its plans for a biosimilar licensing pathway that will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications. Local industry believes the guideline creates an opportunity for the UK to be the first launch market for biosimilars.

UK To Diverge On Biosimilar Data Requirements

The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.

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