After years of waiting, the FDA has finally released its draft guidelines for the development and approval of biosimilars. Now that the industry has a clear path forward, it is essential that you capitalize on the expert commentary of our speakers from Pfizer and Shire in order to best understand how to remain in compliance and reliably push your biosimilar candidates to the market.  |
| Brian Harvey, Pfizer |
Featured Session: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway
Featured Speakers: Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer
Carrie Burke, Director of Government Affairs, Shire
About the Session: This timely session will focus on the latest updates on the
FDA’s user fee structures for biosimilars as well as their 2012 draft guidelines. The most signifi cant aspects of the biosimilar guidelines will be the allowability of foreign referent products, the assignment of unique non-proprietary names, and the extrapolation of multiple indications through shared MOA. The follow-on industry has its strong opinions on all three of these.
- • Grasp how the new legislation helps you overcome the barriers to market entry
- • Reassess your application and patent defense methods in light of the FDA’s “wall” around innovator data
- • Structure your analytical teams around the comparability methods that regulatory reviewers prefer
- • Frontload your capacity for factor certifi cation, PK studies, and other means to equate point of origin and/or functionality to regulators
- • Overcome additional roadblocks to biosimilar interchangeability at the state level
- • Strategize methods for turning unique name requirements into competitive advantage
- • Protect your budgets from any new studies that may be required if extrapolation of indications is not allowed
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