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

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 requirements to show the proposed interchangeable product is expected to produce the same clinical results as the reference product in any given patient.

Since the originator product is a biological medicinal product, it is also necessary to understand what constitutes a biological medicinal product.

What is a biological medicinal product?

The legal definition of 'biological medicinal product' is set out at section 3.2.1.1 (b), Part I, Annex I of Directive 2001/83/EC, as amended (the Pharmaceutical Code), as follows:

'A biological medicinal product is a product, the active substance of which is a biological substance. A biological substance is a substance that is produced by or extracted from a biological source and that