Biosimilars 2015

Interact with FDA and international agencies to discuss the latest updates and outlooks for biosimilar regulation, while examining the potential implications for patients and HCPs.

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Session 1: Biosimilars in the US & Europe

Session Chair(s)

Mark McCamish, MEd, PMP

President and Chief Executive Officer

Forty Seven Inc., United States

In this session we will review the latest scientific and regulatory developments in the US and Europe. Leading FDA and EMA regulators will provide their perspective on the approval of the first biosimilars in the US, biosimilar monoclonal antibodies, the development and revision of guidelines and efforts to achieve convergence of requirements between the US and Europe. We will also hear the stories of the approvals of the first two biosimilars in the US, a cytokine and a monoclonal antibody, directly from industry leaders who were closely involved with this work. Overall, this session with provide a comprehensive overview of where the cutting edge of the science and regulations for biosimilars stands today.

Speaker(s)

Keynote: Beyond the Finish Line: Biosimilars in the US

Steven Kozlowski, MD

FDA, United States

Director, Office of Biotechnology Products, OPQ, CDER

Biosimilars 2.0 in the EU: Learnings, Challenges, and External Perceptions

Niklas Ekman

Finnish Medicines Agency, Finland

Senior Researcher

The First Biosimilar in the US – The Company Perspective

Mark McCamish, MEd, PMP

Forty Seven Inc., United States

President and Chief Executive Officer

Biosimilars 2015

Session 1: Biosimilars in the US & Europe

Session Chair(s)

Mark McCamish, MEd, PMP

Speaker(s)

Keynote: Beyond the Finish Line: Biosimilars in the US

Biosimilars 2.0 in the EU: Learnings, Challenges, and External Perceptions

The First Biosimilar in the US – The Company Perspective

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