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FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue

Dec 28th, 2011

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FDA has released for comment a draft of its 2012-2017 performance goals for authorizing biosimilar products as called for under the terms of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  Comments are due by January 6, 2012.

Covered in the draft are sections on: ● review performance goals ● first cycle review performance ● review of proprietary names to reduce medication errors ● major dispute resolution ● clinical holds ● special protocol assessment ● meeting management goals, and ● definitions and explanation of terms.

The performance goals release was followed by a public meeting on December 16 at FDA’s White Oak campus in Silver Springs, Maryland to obtain input on the proposal.  Presentations at the meeting were given by FDA and by stakeholders in a series of panels.

Speaking for FDA were Office of Planning and Analysis Director Patrick Frey; Medical Products and Tobacco Deputy Commissioner Stephen Spielberg; and Office of Planning and Informatics Director Theresa Mullin.

The public stakeholder panelists included representatives from the Academy of Managed Care, Duke University School of Medicine and RetireSafe, a senior citizen’s advocacy group.  Providing industry perspectives were representatives from the Biotechnology Industry Organization (BIO), the Generic Pharmaceutical Association (GPhA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

[More on the December meeting and a review of the agency’s efforts to date on implementation of the biosimilars legislation is provided for subscribers beginning on page 2.  Nonsubscribers can purchase the full story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA

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