Emerging markets considerations for biosimilar development and registration

Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

Open Access

Emerging markets considerations for biosimilar development and registration

4th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Christopher J Leintz

Pfizer Inc., USA

Keynote: J Bioanal Biomed

Abstract :

Emerging markets are taking on a greater level of prominence in the pharmaceutical industry. They offer true growth areas in a world where developed markets face constant pricing pressures. As a result, the level of activities in emerging markets is growing exponentially. Nowhere is this more visible than in the arena of biosimilars. Emerging markets offer the alluring promise of willing clinical trial participants and cheaper operational costs for running studies. They also tempt industry with market expansion to fuel the growth the biotech industry so keenly desires. While the benefits of bringing research and eventual MAA filings to emerging markets does have a clearly visible upside, caution must also be exercised. Whether its localization, indemnification, or cultural considerations, emerging markets must be approached in an appropriate way; a way in which industry and patients can maximize the potential of this new pharmaceutical frontier.

Biography :

Christopher J Leintz, DBe, MPH, currently is the Director and Emerging Markets Strategy Lead for biosimilars at Pfizer. He received his Doctorate in Bioethics from Loyola University Chicago and his MPH from the University of Illinois at Chicago. He developed a keen interest in human rights and healthcare access from his time serving in the United States Peace Corps. He continues to pursue these interests in his current role. He has worked in the pharmaceutical industry since 2016, focusing primarily on regulatory drug development and clinical research.


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