1. Pink Sheet

UK Pioneers Tailored Biosimilars Pathway With Fresh Guidance

Updated Guidance Setting Out MHRA’s New Licensing Route Welcomed By Industry Bodies

 
• By Dave Wallace

Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation. It has been warmly welcomed by the off-patent industry both locally and internationally.

Mountain Explorer Clouds Pioneer
The UK is pioneering a tailored approach to biosimilar registration • Source: Alamy

Updated UK guidance on the country’s new post-Brexit licensing pathway for biosimilar medicines has been welcomed by the off-patent industry, both locally and internationally.

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