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New UK Biosimilars Pathway Suffers Setback

MHRA Consultation Review Delayed Due To ‘Intense COVID-19 Activities’

 
• By Dave Wallace

The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.

Alarm Clock COVID coronavirus
The MHRA’s COVID-19 activities have delayed the new pathway • Source: Shutterstock

The planned implementation of a new UK licensing pathway for biosimilars has been pushed back indefinitely from the start of this year, with the country’s Medicines & Healthcare products Regulatory Agency citing “intense COVID-19 activities” as the cause of a delay in the consultation process.

In October 2020, the MHRA had set out its plans for a biosimilar licensing pathway that would typically not require comparative efficacy data and would consider approved biosimilars interchangeable with their reference products for all indications

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