1. Pink Sheet

UK Lays Out Reduced Data Pathway For Biosimilars

Chance For Post-Brexit Country To Be First Launch Market

 
• By Dave Wallace

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.

Highways and interchanges in Austin Texas from above
Approved biosimilars are to be considered interchangeable in the UK • Source: Shutterstock

A proposed new 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 approved biosimilars will be considered interchangeable with their reference products for all indications.

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