Updated UK guidance on the country’s new biosimilars licensing pathway has been welcomed by the off-patent industry, both locally and internationally. The UK Medicines and Healthcare products Regulatory Agency’s latest guidance – published after a stakeholder consultation – confirms that the MHRA will be pioneering the approach of not typically requiring comparative efficacy data, while approved biosimilars will be considered to be interchangeable with their reference products, albeit without pharmacy-level substitution.
UK Pioneers Tailored Biosimilars Pathway With Fresh Guidance
Updated Guidance Setting Out MHRA’s New Licensing Route Welcomed By BBA And IGBA
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, receiving a warm welcome from the off-patent industry both locally and internationally.
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