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UK Lays Out Reduced-Data Pathway For Biosimilars

Creates Opportunity For Country To Be First Launch Market, Industry Says

Executive Summary

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.

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