Biosimilars Webinar - July 23, 2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop participated as panelists, along with Michael Fuller as the moderator.

- Excerpt from Presentation: Biologics Overview:

Biologics Price Competition and Innovation Act (“BPCIA”) -

• Signed into law March 23, 2010, as part of the Patient Protection and Affordable Care Act of 2009; amends §351 of Public Health Services Act.

• Codified at 42 U.S.C.§262.

• Creates an abbreviated approval pathway for ‘biological products’ that are demonstrated to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product.

Please see full presentation below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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