Biosimilars
Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP
Biosimilars

The following Life Sciences guidance note Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP provides comprehensive and up to date legal information covering:

  • Biosimilars
  • What is a biosimilar?
  • What is a biological medicinal product?
  • Scientific background of biosimilars
  • EU regulatory framework for biosimilars
  • Legal basis for a biosimilar marketing authorisation in the EU
  • Other procedures for obtaining a marketing authorisation for biosimilars in the EU
  • Difficulties in manufacturing biosimilars
  • Pharmacovigilance monitoring
  • Market access
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

What is a biosimilar?

A similar biological medicinal product (commonly termed 'biosimilar') is a medicinal product that is similar to a biological medicinal product (the originator product, also known as the 'reference product') that has already been granted a marketing authorisation in the EU/EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes. In the United States (US), biosimilars are often termed 'comparable biologics' or 'follow-on biologics'.

The US has defined the term 'Interchangeable Biological Product' which generally requires a higher standard of interchangeability than in Europe, as such products have to meet additional