Intellectual property and regulatory interplay in biosimilars

7^th European Biosimilars Congress

May 15-16, 2017 Munich, Germany

Christoph Volpers

Michalski H�¼ttermann & Partner, Germany

Keynote: J Bioanal Biomed

Abstract :

Driven by strong, albeit diverging interests of various stakeholders like pharmaceutical companies, legislators, health care providers and patient interest groups, the global biosimilar market is expected to reach more than US-$ 40 billion by mid of the next decade. Whereas, the regulatory pathway for biosimilars in Europe has been validated and refined over the last ten years, the US is still struggling for guidance and interpretation of its biosimilars legislation where regulatory and patent issues are much more connected. The talk will give an update on recent case law in this field and discuss strategic implications from various perspectives.

Biography :

Christoph Volpers has done his PhD in Molecular Biology from the University of Mainz, Germany, and an MBA from Bradford University, UK. He has almost 15 years of experience in Intellectual Property and Licensing. Before he joined the patent law firm, Michalski Hüttermann & Partners, Dusseldorf/Munich, as Senior Patent Consultant in early 2015, he was the Director IP Biologics of the Teva Pharmaceutical Industries for six years with global responsibility for innovative biologics and biosimilar products. He is the Founder of a biopharmaceutical consultancy firm, author of more than 20 publications and a member of the Licensing Executive Society.

Email: volpers@mhpatent.de