This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied
[for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.
This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles of establishing biosimilarity.
Document details
| Download document | Draft guideline on similar biological medicinal products |
|---|---|
| Reference number | CHMP/437/04 Rev. 1 |
| Status | draft: consultation open |
| First published | 02/05/2013 |
| Last updated | 02/05/2013 |
| Consultation start date | 02/05/2013 |
| Consultation end date | 31/10/2013 |
| Email address for submissions | bmwpsecretariat@ema.europa.eu |