FDA approves first US biosimilar from Sandoz
Sandoz’s Zarxio is biosimilar to Amgen’s Neupogen (filgrastim), which was originally licensed in 1991.
Zarxio is approved for the same indications as Neupogen, and can be prescribed for patients with cancer receiving myelosuppressive chemotherapy; acute myeloid leukemia receiving induction or consolidation chemotherapy; cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.
This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of Obamacare, or the Affordable Care Act that President Obama signed into law in March 2010.
But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.
Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly 7.5 million patient-exposure days of experience.
For the approval, the FDA designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products,” the FDA said in a statement. “
While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.”
In a February court filing, Sandoz agreed to not launch "until the earlier of April 10, 2015, or a ruling in Sandoz’s favor on Amgen’s Motion,” according to a lawsuit filed in the US District Court of California. "Amgen is seeking a preliminary injunction to prevent Sandoz from launching before the Court can decide whose reading of the BPCIA is correct," IP attorney Stacie Ropka from Axinn, Veltrop & Harkrider told BioPharma-Reporter.com. "If the preliminary injunction is granted then the Court will order Sandoz to refrain from launching until some benchmark is achieved."