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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