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
This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles of establishing biosimilarity.
|Download document||Draft guideline on similar biological medicinal products|
|Reference number||CHMP/437/04 Rev. 1|
|Status||draft: consultation open|
|Consultation start date||02/05/2013|
|Consultation end date||31/10/2013|
|Email address for email@example.com|