No Six-Month Wait for Biosimilars After FDA Approval-US Supreme Court
The US Supreme Court last month (June 12, 2017) in Sandoz v. Amgen ruled unanimously in favor of generic that biosimilar companies will not have to wait an additional six months after FDA approval to launch their product.
The case concern a biologic product filgrastim marketed by Amgen as Neupogen since 1991 and claims to hold patents on methods of manufacturing and using filgrastim. In May 2014, Sandoz filed an application with the FDA seeking approval to market a filgrastim biosimilar under the brand name Zarxio, with Neupogen as the reference product. On July 7, 2014, FDA informed Sandoz that it had accepted the application for review. One day later, Sandoz notified Amgen both that it had submitted an application and that it intended to begin marketing Zarxio immediately upon receiving FDA approval, which it expected in the first half of 2015. Sandoz later confirmed that it did not intend to provide the requisite application and manufacturing information under §262(l)(2)(A) and informed Amgen that Amgen could sue for infringement immediately under §262(l)(9)(C).
42 U. S. C. §262(l), which was enacted as part of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The BPCIA governs a type of drug called a biosimilar, which is a biologic product that is highly similar to a biologic product that has already been approved by the Food and Drug Administration (FDA). Under §262(l), an applicant that seeks FDA approval of a biosimilar must provide its application materials and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The applicant then must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially.
Federal court concluded that an applicant’s biosimilar must already be “licensed” at the time the applicant gives notice, while addressing one of the questions at issue in the case: whether an applicant must provide notice after the FDA licenses its biosimilar, or if it may also provide effective notice before licensure. Section 262(l)(8)(A) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”
Supreme court granted Sandoz’s petition for certiorari, one of the question presented to the supreme court is whether the applicant must give notice to the manufacturer after, rather than before, obtaining a license from the FDA for its biosimilar.
Biologic manufacturers already have 12 years of market exclusivity, and Sandoz argued that the Federal Court ruling essentially gave Amgen an additional six months.
The Supreme Court concluded that an applicant may provide notice before obtaining a license (disagreeing with Federal court).
Decision click here
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