BayBio Therapeutic Area Series - Biosimilars, Second Generation Biologics and Generics
Jun. 25, 2009KPMG
Mountain View, CA
www.baybio.org/wt/home/Biosimilars
Description:
BayBio Therapeutic Area Series - Biosimilars, Second Generation Biologics and Generics
Webster Sun, Senior Practice Executive, Brand Management Practice, will moderate a panel discussion on the opportunities and challenges surrounding generic versions of many blockbuster biopharmaceutical products following their patent expiration.
Abstract:
With patent protections expiring on the first biopharmaceutical products, several generic manufacturers are gearing up to move into the new marketplace. While a regulatory pathway exists for approval of generic versions of small molecule drugs there is no legally-approved regulatory pathway to bring follow-on biologics to market in the US. Currently, several bills are working their way through Congress that, if approved, would permit the FDA to approve generic versions of many blockbuster biopharmaceutical products following their patent expiration. A panel of regulatory experts, policymakers and life sciences companies on both sides of the debate will discuss the opportunities, the challenges and what approval of such legislation would really mean for the life sciences industry.
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George Schmidt, Senior Vice President of the Sales Practice, discusses the impact of the current pharma and biotech landscape on sales forces and Training & Development departments....
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