Legislation, Regulations & Guidances (Europe)

Guidances

• Guideline on similar biological medicinal products containing interferon beta (Comments due May 2012)
• Draft Guidance: Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies Comments due by May 31, 2011
• Draft Guidance: Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use Comments due by May 31, 2011
• Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use (released March 2009)
• Guideline on Similar Biological Medicinal Products (released October 2005)
• Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (released December 2003)
• Concept Paper on the Development of a Committee for Proprietary Medicinal Products (CPMP) Guideline on Comparability of Biotechnology-Derived Products - June 24, 1998
• Consultation re: Concept Paper EMEA Biosimilar Monoclonal Antibodies (released October 2009 with comments due January 31, 2010)

European Medicines Agency

• Questions and Answers on biosimilar medicines (similar biological medicinal products) - October 22, 2008
• Scientific Guidelines for Human Medicinal Products