Regulatory framework for biosimilar medicinal products in the UK and EU

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

Practice notes

Regulatory framework for biosimilar medicinal products in the UK and EU

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

Practice notes

This Practice Note explains what a similar biological medicinal product or Biosimilar is. It sets out the UK and EU regulatory framework for biosimilars and discusses biosimilar marketing authorisations, pharmacovigilance monitoring and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly considers the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. Finally, it covers the main patent issues regarding biosimilars and the application of the Bolar-type exemption and considerations on the ‘clearing the way’ principle.

What is a biosimilar?

A similar biological medicinal product (commonly termed a biosimilar) is a medicinal product that is similar to a biological medicinal product (the originator product, also known as the reference medicinal product) that has already been granted a marketing authorisation (MA) on the basis of a complete dossier, ie with the submission of quality, pre-clinical and clinical data, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing

Jurisdiction(s):

United Kingdom

Key definition:

Biosimilar definition

What does Biosimilar mean?

A medicinal product that is similar to a biological medicinal product (the originator or ‘reference’ product) that has already been granted a authorisation'>marketing authorisation in the EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes.

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