Biosimilar Medicines | Articles
 Scientific Articles & Presentations on Biosimilar Medicines
Breaking Barriers to Biologics Access
A presentation delivered at the IGPA Conference 2011, Cape Town, South Africa
• Suzette Kox | Senior Director Scientific Affairs | EGA
2-3 November 2011
Manufacturing and Quality Aspects for Biosimilars
A presentation delivered at the European Commission Project Group Meeting at the Danish Medicines Agency, Copenhagen
• Dr. Klaus Graumann | Global Head Technical Development Operations | Sandoz Biopharmaceuticals
24 October 2011 EGA Presentations at the EMA Closed Workshop on Biosimilar mAbs Guideline and mAbs Immunogenicity Guideline
• Ildiko Aradi • Antonio da Silva • Karl Heinz Emmert • Nicole Filser
• Thomas B. May • Mark McCamish • Joerg Windisch
24 October 2011
EGA Submission regarding US Approval Pathway for Biosimilar and Interchangeable Biological Products (Docket N° FDA-210-N-0477)
Global Development for Biosimilar Medicines in the Light of US and International Developments
A presentation delivered at the 3rd EMA-EGA Info Day, London
• Ingrid Schwarzenberger | Head Global Regulatory Affairs Biopharmaceuticals | Sandoz Biopharmaceuticals Development and Member of the EGA-European Biopharmaceuticals Group
10 November 2010
FDA Public Hearing: Approval Pathway for Biosimilar and Interchangeable Biological Products
Comments by the EGA
• Joerg Windisch, PhD | Vice-Chair of EGA’s Biopharmaceuticals Group | EGA
FDA White Oak Campus, Silver Spring (MD), 2-3 November 2010
8th EGA Annual International Symposium on Biosimilar Medicines
A presentation delivered during the event
• Greg Perry | Director General | EGA
London, 2-3 September 2010
IGPA's View on Implementation of the WHO Guidelines on Similar Biotherapeutic Products (SBPs)
A presentation delivered at the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biotherapeutics products
• Martin Schiestl | Scientific and Regulatory Advisor | Sandoz Biopharmaceuticals
Seoul, 24-26 August 2010
Interview to Suzette Kox, Senior Director Scientific Affairs, EGA
Article published 1 August 2010 on PHARMACEUTICAL TECHNOLOGY EUROPE (Volume 22, Issue 8)
The EU Market Environment for Biosimilar Medicines
A presentation delivered at the 12th Annual IGPA Conference, Montreal (Canada)
• Suzette Kox | Senior Director Scientific Affairs | EGA
30 September - 2 October 2009
Biosimilar Medicines | Towards Global Development and Monoclonal Antibodies
A presentation delivered at the
7th EGA Annual Symposium on Biosimilar Medicines, London
• Greg Perry | Director General | EGA
23-24 April 2009
The Biosimilar Framework in the European Union
A presentation delivered at the
Japan Generic Medicines Association Seminar in Tokyo, Japan
• Suzette Kox | Senior Director Scientific Affairs | EGA
19 February 2009
The EGA’s Perspective on Biosimilar Products
A presentation delivered at the
Japan Generic Medicines Association Seminar in Tokyo, Japan
• Martin Schiestl, PhD | Head Analytics and Pharmaceutical Development,
Biopharmaceutical Operations |
Sandoz
17 February 2009
Biosimilars: Growing the Concept
• Cecil Nick, BSc (Hons.), vice president, biotechnology, PAREXEL Consulting, UK
• Regulatory Affairs Journal Pharma | October 2008
The article represents an independent view and not necessarily the position of the EGA.
Reproduced with permission from the author.
Biosimilar Medicines: Europe’s New Opportunity
• Suzette Kox, Senior Director Scientific Affairs, EGA
Presentation To the Finnish Generic Association Interest Group
Event on Biosimilar Medicines
31 October 2008 | Helsinki, Finland
Biogenerics and Legislative Issues
• Suzette Kox, Senior Director Scientific Affairs, EGA
Presentation To the GPhA's 2008 Annual Policy Conference
19 September 2008, Washington, DC
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)
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