Biosimilar Medicines | Regulatory
 EU
Legal & Regulatory Framework for Biosimilar Products
European Commission Testimony
How the European Union Reviews and Approves ‘Follow-on
Biologics’
or Biosimilar Products
• Before the US Senate HELP Committee
Nicolas Rossignol - 8 March 2007
Current Legal Framework:
Annex I to Directive 2001/83/EC
as amended by Commission Directive 2003/63/EC.
• See Part II, 4
Legal Framework from 20 November 2005: EU Directive on medicinal products for human use
• See Article 10.4
EU Regulatory Pathway for Biosimilars:
EU Regulation on laying down Community procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency
• See “Centralised procedure”
Comparability Guidelines for Biosimilar Products
All adopted guidelines on biosimilar medicinal products
are available on the following pages of the EMEA website under the rubric:
“Scientific Guidelines for Human Medicinal Products”
Biologicals Guidelines
• Includes Comparability & Biosimilarity
Multidisciplinary
Guidelines
• Scroll half-way down the page to “Biosimilar
Medicines”
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