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The FDA is taking steps to more efficiently manage review and licensure pathways to facilitate biosimilar competition. These steps include:
- Modernizing policies governing the development of biosimilars to make it more efficient
- Educating clinicians, payors and patients about biosimilar products and the rigorous evaluation they must go through
- Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies
In the last two months of 2018 the FDA approved three new biosimilar products. And, in December the FDA released three new guidances and a proposed rule concerning biosimilars.
- Guidances:
- Questions and Answers on Biosimilar Development and the BPCI Act (Dec. 2018)
- New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (Dec. 2018)
- Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. (Dec. 2018)
- Proposed rule:
- Definition of the Term “Biological Product” (Dec. 2018)
Nicholas Mitrokostas, partner in the Boston office of Goodwin Procter LLP and Daniel Orr, partner in the Washington, DC office of Womble Bond Dickinson LLP, will provide an overview of the FDA’s current review process, approval standards, and related issues confronting sponsors of reference biologics and biosimilars. Over the course of 90-minutes they’ll discuss:
- Common problems concerning reference product exclusivity
- How FDA currently reviews and decides whether to approve a biosimilar application
- Regulatory and IP considerations and implications of seeking a carve-out of therapeutic indications in the aBLA product label
- Considerations and implications of using foreign approved products in clinical studies supporting approval of an aBLA, or running clinical trials in foreign countries
- Insider insight into FDA’s recently proposed rule and recent guidances
This presentation will help you understand current regulatory issues and problems confronting manufacturers of both reference biologics and biosimilars and the relevant intellectual property considerations that could impact regulatory strategy. Register today.
Who Will Benefit
- Executive suite
- Strategic planners
- Regulatory affairs
- R&D
- Marketing/sales
- Legal counsel
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Webinar plus Audio Recording/Transcript
Learn more
Best Value! You’ll have access to one log-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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Webinar only
Learn more
You get one log-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.
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$287
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24/7 Encore plus Audio Recording/Transcript
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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24/7 Encore Presentation
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials.
|
$287
|
|
|
Audio Recording/Transcript
Learn more
You'll receive an audio recording and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately two weeks after the session.
|
$287
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