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Nov. 2 — Amgen’s launch of its FDA-approved biosimilar of AbbVie’s Humira could be delayed three years by AbbVie’s patent infringement claims, according to a Nov. 1 court filing ( AbbVie, Inc. v. Amgen, Inc. , D. Del., No. 1:16-cv-666, 11/1/16 ).
AbbVie filed litigation against Amgen in the U.S. District Court for the District of Delaware on Aug. 4., asserting that Amgen’s Amjevita, its Humira biosimilar, infringes 10 Amgen patents and violates the Biosimilar Price Competition and Innovation Act (BPCIA), which creates an abbreviated approval pathway for biosimilars ( 10 LSLR, 8/19/16 ). On Sept. 23, the Food and Drug Administration approved Amgen’s application for U.S. marketing of Amjevita ( 10 LSLR, 9/30/16 ).
Amgen and AbbVie filed a joint stipulation of dismissal of the count of BPCIA violation on Oct. 28, indicating that Amgen had agreed to honor the 180-day notice requirement of the BPCIA. On Nov. 1, the parties filed a proposed scheduling order with the court for the patent infringement counts, which, if approved, would stretch the litigation into 2019. An Amgen spokeswoman confirmed a delay in the launch of Amjevita at least through 2017 in a Nov. 2 e-mail to Bloomberg BNA.
Thomas J. Kowalski of Vedder Price P.C., New York, told Bloomberg BNA in a Nov. 2 e-mail, “It seems that at-risk biosimilars are more likely to see a delay in their launch.”
The delay will extend AbbVie’s exclusivity for Humira (adalimumab), which in 2015 brought in $8.4 billion in global sales.
A biosimilar is a biologic drug product that is highly similar to an FDA-approved biologic. The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated approval pathway for biosimilars that partly relies on data submitted for FDA approval of the original biologic, also known as a reference product (RP).
The U.S. Court of Appeals for the Federal Circuit in Amgen v. Sandoz interpreted key provisions of the BPCIA to mean that the exchange of manufacturing and patent information between the biosimilar applicant and the RP sponsor is optional and that, if the applicant doesn’t provide the information, the RP sponsor may immediately sue for patent infringement. If the applicant does provide the information, the RP sponsor may sue for infringement of patents on the mutually-agreed upon list.
The Sandoz court also held that the 180-day notice of commercial marketing that the applicant is to provide to the RP sponsor can only be provided after the FDA approves the biosimilar application.
According to AbbVie’s complaint, Amgen participated in the compilation of a list of AbbVie patents that could be infringed by its Humira biosimilar but didn’t respond when AbbVie asked it to confirm that it would honor the Sandoz court’s interpretation of the 180-day notice requirement.
On July 5, the Federal Circuit further clarified the provisions of the BPCIA in Amgen v. Apotex, which dealt with Apotex’s biosimilar of Amgen’s Neulasta (pegfilgrastim). The court stated that the 180-day notice requirement is mandatory, even if an applicant like Apotex and unlike Sandoz did participate in the exchange of patent information.
Kowalski told Bloomberg BNA, “Amgen’s stipulation of dismissal in the Humira biosimilar litigation is consistent with the position Amgen took in its case against Apotex, insisting that a generic must provide the 180 days notice, and obtaining a Federal Circuit decision that the notice is mandatory.”
The joint request to dismiss the BPCIA violation count having been made, the parties have outlined their proposed schedule for the patent infringement litigation. As a result, the release of Amjevita could be delayed by three years even though the FDA has approved its being sold in the U.S.
Bob Bradway, Amgen’s CEO, told his shareholders in an Oct. 27 conference call that, given the pace of litigation, “it’s unlikely that this matter will be clarified in time for us to launch in 2017.” An Amgen spokeswoman confirmed this in a Nov. 2 e-mail to Bloomberg BNA and added, “We are currently evaluating various launch scenarios.”
To contact the reporter on this story: John T. Aquino in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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