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UK Pioneers Tailored Biosimilars Pathway With Fresh Guidance

Updated Guidance Setting Out MHRA’s New Licensing Route Welcomed By BBA And IGBA

Executive Summary

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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