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

The following Life Sciences practice 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...

Biosimilars

IP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred to in UK law as ‘IP completion day’), transitional arrangements ended and significant changes began to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for Life Sciences?

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

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