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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