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UK Lays Out Reduced-Data Pathway For Biosimilars

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

 
• By Dave Wallace

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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The MHRA is planning to reduce the data burden for applicants seeking biosimilar approval • Source: Shutterstock

A fresh licensing pathway for biosimilars has been released for public consultation by the UK Medicines & Healthcare products Regulatory Agency, setting out the reduced requirement for comparative efficacy data that the MHRA promised earlier this year, as well as confirming that all approved biosimilars will be considered interchangeable with their reference products for all indications.

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