Christoph Volpers
Michalski Hüttermann & Partner, Germany
Title: Intellectual property and regulatory interplay in biosimilars
Biography
Biography: Christoph Volpers
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.