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FDA Announces Approval of First Ever U.S. Biosimilar

Today the FDA announced the first approval of a biosimilar product in the United States under the Biologics Price Competition and Innovation Act (BPCIA). Sandoz’s product, to be sold under the trade name Zarxio, is a biosimilar of Amgen’s Neupogen (filgrastim) product. The FDA approved Zarxio for all five of Neupogen’s indications. As we previously reported, FDA’s approval of Zarxio was expected; earlier this year, both FDA staff and the Oncologic Drugs Advisory Committee unanimously recommended it for approval.

Despite today’s approval, Sandoz’s biosimilar will not enter the market immediately. Sandoz has agreed to stay off the market until April 10, 2015 or a decision from a federal court in California in Amgen’s pending lawsuit, whichever comes sooner. Specifically, Amgen sued Sandoz last October alleging that Sandoz violated the BPCIA by not provided Amgen with a copy of its abbreviated Biologics License Application (aBLA) (see 42 U.S.C. § 262(l)(2)(A)) and by providing a premature notice of commercial marketing prior to the biosimilar product’s approval (see 42 U.S.C. § 262(l)(8)(A)). Amgen’s motions for judgment on the pleadings and preliminary injunction are due to be heard by the court on March 13, 2015, with a decision expected in the near future. We are monitoring this case closely, and will report any developments.

One other note from today’s approval: the FDA has punted for the time being on a naming policy for biosimilars, approving Zarxio with the “placeholder nonproprietary name” of “filgrastim-sndz.” How the FDA will name biosimilars has been the subject of much debate. Unlike small molecules, biosimilars are by definition different from (although similar to) the reference product. Thus, while biosimilars manufacturers will generally want their product to have a nonproprietary name identical to the reference product, reference product sponsors such as Amgen, as well as physicians, have argued that the non-proprietary names should be distinct given that the products are different. According to the FDA, its approval of Zarxio with a placeholder name “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products.” FDA stated that it “has not yet issued draft guidance on how current and future biological products marketed in the United States should be named” and “intends to do so in the near future.” We will cover biosimilars naming in a future post; perhaps, as the FDA puts it, “in the near future.”

Stay tuned.

Categories: BPCIA, FDA, Naming
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