FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for January 2016

Posted on Tuesday, January 26 2016 at 7:38 pm by -

Supreme Court Review in Amgen v. Sandoz – Amgen Decides not to Seek Review; Sandoz is Granted Filing Extension

By: Jennifer Giordano-Coltart, Ph.D. and Carolina M. Wirth

Following the Federal Circuit’s denial to rehear the Amgen Inc. v. Sandoz case en banc,1 Amgen and Sandoz had until January 14, 2016 to file petitions for certiorari with the Supreme Court. At the Federal Circuit level, each party won one of the issues in dispute relating to interpretation of the Biologics Price Competition and Innovation Act (BPCIA). Thus, each party had an opportunity to request Supreme Court review of the issue decided adverse to their position. On December 23, 2015, Sandoz submitted a request for an extension of time until February 16, 2016 to submit its petition. The Chief Justice granted Sandoz’s request on December 29, 2015.2 Amgen, on the other hand, did not file for an extension and did not submit a petition by the January 14th deadline.
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Posted on Friday, January 22 2016 at 4:25 pm by -

BIO and PhRMA Citizen Petition Calls For Detailed Information on Biosimilar Labeling

By:  Jennifer Giordano-Coltart, Ph.D.

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) filed a Citizen Petition (“Petition”) with the Food and Drug Administration (FDA) on December 22, 2015.[1]  The Petition focuses on the labeling requirements for biosimilar biological products licensed under section 351(k) of the Public Health Service Act (PHS Act), as amended by the Biologics Price Competition and Innovation Act (BPCIA).
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Posted on Thursday, January 14 2016 at 4:19 pm by -

AbbVie to FDA: Clinical Support Needed For All Reference Product Approved Indications to Support Interchangeability Designation for Biosimilars

By: Jennifer Giordano-Coltart, Ph.D. and Carolina M. Wirth

On December 16, 2015, AbbVie, Inc. (AbbVie) submitted another Citizen Petition (Petition) to the Food and Drug Administration (FDA) relating to the Biologics Price Competition and Innovation Act (BPCIA) (Docket No. FDA-2015-P-4935).1 The Petition focuses on the standard to be used to determine whether a biosimilar product may be designated as interchangeable with a reference product under Public Health Service Act (PHS Act) §351(k)(4).2 An interchangeable biological product is a product that has established biosimilarity to an FDA-approved reference product and meets additional standards. Such a product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.3 AbbVie takes the position that interchangeability must be established for every condition of use for which the reference product is licensed, regardless of whether the biosimilar applicant intends to label its product for every such condition. AbbVie asks the FDA to “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity.” Petition at 1. Finally, AbbVie requests that the FDA convene a Part 15 hearing to receive public comment and then issue guidance on the issue.
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