UK’s MHRA updates its guidance on licensing biosimilars

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on biosimilars, softening the rules in order to enable these products to reach the UK market faster.

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The MHRA originally published guidance on 31 December 2020 for Great Britain (England, Wales and Scotland) covering marketing authorization applications for biosimilars, which basically stated that the UK would follow the European Union (EU) biosimilar guidelines [1].

The guidance was updated on 6 May 2021 and, although the main principals still follow those of the EU, the UK has introduced some changes. One of those is that ‘confirmatory’ clinical trials in humans ‘may not be necessary’.

Guidance on the licensing of biosimilar products
Date: 6 May 2021

The guidance states that ‘in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach’. This change in the way biosimilars are approved has been praised by Mark Samuels, Chief Executive of the British Biosimilars Association. He said that ‘the new guidance puts the UK ahead of the rest of Europe when it comes to regulatory innovation and could provide a further catalyst to a biosimilar boom in the next decade’.

The change could also mean that the UK’s National Health Service (NHS) could gain access to biosimilars a year earlier than under the old regime. Although this will also depend on patent and market exclusivities. If earlier access becomes a reality in the UK, this could lead to the ‘NHS saving hundreds of millions of pounds’, according to Mr Samuels.

Mr Samuels adds that the new guidance was based on ‘15 years of clinical experience, tracking patient outcomes through follow-up studies’, as well as on ‘robust and rigorous data that showed confirmatory trials were unnecessary’.

Over the next 10 years at least 20 biosimilars are expected to be launched in the UK.

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1. GaBI Online - Generics and Biosimilars Initiative. UK’s MHRA publishes guidance on licensing biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: 

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Source: MHRA

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