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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