Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Biosimilar definition

What does Biosimilar mean? In legal practice, a biosimilar is a biological medicine developed to be highly similar to an already authorised biological “reference” product, enabling reliance on comparative quality, non‑clinical and clinical data rather than a full standalone dossier. EU and UK medicines legislation, supported by EMA/MHRA guidance, use the expression “similar biological medicinal product” (biosimilar). It is not a generic: biologicals are made in living systems and inevitable differences in materials and processes mean approval depends on a stepwise comparability exercise showing no clinically meaningful differences in quality, safety or efficacy versus the reference. In Great Britain, marketing authorisation is granted...

Biosimilars: UK and EU Regulation, Interchangeability, Pharmacovigilance, Market Access and Patent Strategies (Bolar, Clearing the Way, UPC), with a Brief US FDA Overview

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Practice notes

This Practice Note sets out what are termed ‘Biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations (MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court (UPC), together with the scope for development of its jurisprudence concerning biosimilars.

What is a biosimilar?

A biosimilar is a biological medicinal product that is similar to a biological medicinal product—the originator, also referred to as the reference medicinal product—which has already been granted a MA on the basis of a complete regulatory dossier, ie through submission of full pre-clinical and clinical data...

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Web page updated on 21/05/2026

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