Christopher J Leintz
Pfizer, Inc., USA
Title: Emerging markets considerations for biosimilar development and registration
Biography
Biography: Christopher J Leintz
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.
