New UK Biosimilars Pathway Suffers Setback
MHRA Consultation Review Delayed Due To ‘Intense COVID-19 Activities’
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.
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The UK has used a special legislative process to temporarily authorize the use of the BNT-162b2 vaccine, with the first 800,000 shots expected to be delivered within days.
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.
The IGBA has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating healthcare professionals.