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Monday, June 25 • 3:00pm - 4:15pm
#144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

No matter what position a company plays in the biopharmaceutical market (innovator or not), biosimilars will bring new challenges. The key challenge companies must face is how they will adapt their product development and commercialization strategies to be successful. Manufacturers have started to realize that biosimilars require not only a unique development pathway but also a more tailored go-to-market approach.
While much has been said about the need to modify the commercial support required for biosimilars, the role of medical affairs and how it needs to evolve to guide biosimilar product development strategy is yet to be defined. Similarly, the role of medical affairs in shaping defense strategies in the face of biosimilar competition has not been explored.
This session will analyze three key challenges to the development and commercialization of biosimilars: 1) regulatory uncertainty; 2) development complexity; and 3) lack of stakeholder confidence and will discuss how medical affairs is uniquely positioned to help manufacturers address these challenges and how this function can evolve to better serve pharmaceutical companies.

Learning Objectives

Describe the three key challenges to biosimilars development and commercialization; Discuss how medical affairs is uniquely positioned to help address those challenges; Identify how medical affairs is organized in this growing field.


Bryan Katz, MBA


Medical Affairs Perspective
Richard Markus

Javier Coindreau, MD

Christiane L. Arsever, MD


Christiane Arsever

US Medical Affairs, Strategy Leader - Biosimilars, Merck & Co., Inc.
Dr. Arsever received her B.A. and M.D. from the Univ. of Michigan in Ann Arbor, completed her residency in internal medicine at Northwestern University Med. Center in Chicago, and a research fellowship in Rheumatology at Univ. of Michigan Medical Center. Dr. Arsever has been at Merck... Read More →

Javier Coindreau

Vice President, Biosimilars Global Medical Affairs, Pfizer Inc
Rheumatologist with ample experience in biologics development and commercialization in the Global and regional scope. Leading Biosimilars organizations in the US and Global settings since 2010 from early development, launch and life-cycle management for the largest BIosimilars portfolio... Read More →
avatar for Bryan Katz

Bryan Katz

Managing Director, Syneos Health
Bryan is a product development specialist with more than 20 years of experience across the pharma/ life sciences industry. With projects spanning integrated [clinical-commercial] program planning, deal and transformation strategy, Bryan has delivered over $1bn in accretive enterprise... Read More →
avatar for Richard Markus

Richard Markus

Vice President, Global Development, Amgen Inc.
Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Forum