Biosimilar Medicines | Articles
 Scientific Articles & Presentations on Biosimilar Medicines
How Quickly Can EU Patients Benefit from the EU’s Lead Regarding Biosimilar Medicines?
• Suzette Kox, Sr Director Scientific Affairs, EGA
Presentation to the DIA Conference
March 2008, Barcelona
EGA WELCOMES APPROVAL OF FIRST BIOSIMILAR EPOETIN
The new biosimilar medicines, based on one development, have been shown to
match a previously approved reference product in terms of quality, safety and efficacy...
• EGA Press Release
3 September 2007, Brussels
Erythropoietin
Informal consultation of working group on
regulatory evaluation of therapeutic biological medicines
• EGA Presentation
WHO 19-20 April 2007, Geneva
The Comparability and Regulation of Biosimilars
Informal consultation of the working group on regulatory
evaluation of therapeutic
biological medicines
• EGA Presentation
WHO 19-20 April 2007, Geneva
Confronting the Challenges in Developing a Biosimilar Medicinal Product
Cecil Nick - PAREXEL Consulting, Uxbridge UK
• Published as Clinical Research Manual Supplement 21
Copyright © 2006 - Euromed Communications (with permission)
Further details available at www.euromed.uk.com.
Biosimilaires: un nouveau cadre légal plus favorable au développement
Barbara Bertholet - Avocate associée, Adamas Law Firm
• Article published in BIOTECHNOLOGIES & FINANCES - No 243
2 mai 2005 (reproduced with permission)
Formulating a Development Program for a Biosimilar Medicinal Product
Cecil Nick, BSc (Hons.) FTOPRA, Director
PAREXEL Consulting, UK
• Article presented to TOPRA (The Organisation for Professionals in
Regulatory Affairs) for publication in the Regulatory Rapporteur.
(reproduced with permission from the author)
Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals
Robert L. Zeid, Principal Consultant, TLI Development, Oak Island, North Carolina
• Drug Information Journal, Vol. 34, pp. 919–959, 2000
(reproduced with permission)
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