FDA approves Novartis’ Zarxio as first biosimilar in US
The FDA announced Friday the approval of Novartis’ Zarxio (filgrastim-sndz) as the first biosimilar product authorised in the US. The therapy, to be marketed by the company’s Sandoz unit, is a biosimilar version of Amgen’s Neupogen (filgrastim), which was originally cleared in 1991.
Commenting on the news, FDA Commissioner Margaret A. Hamburg remarked “biosimilars will provide access to important therapies for patients who need them.” She added “patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
According to the FDA, Zarxio is approved for the same indications as Neupogen, including for patients with cancer receiving myelosuppressive chemotherapy and those with acute myeloid leukaemia receiving induction or consolidation chemotherapy. Zarxio can also be used in patients with cancer undergoing bone marrow transplantation, those undergoing autologous peripheral blood progenitor cell collection and therapy, as well as in patients with severe chronic neutropenia.
Clearance of Zarxio was expected after an FDA advisory panel in January voted unanimously in favour of approval of the drug for all five conditions for which Neupogen is currently marketed. The drug is marketed in more than 60 countries outside the US under the name Zarzio.
The FDA noted that the approval of Zarxio was based on review of evidence that demonstrates Zarxio is biosimilar to Neupogen, including the pivotal head-to-head PIONEER study. However, the agency indicated that Zarxio has not been approved as an interchangeable product. The agency clarified that under the Biologics Price Competition and Innovation Act, a product that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
The regulator added that it has designated a placeholder nonproprietary name for Zarxio as filgrastim-sndz. However, the FDA said “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.”
Sandoz declined to provide specific price details for Zarxio, but Carol Lynch, global head of biopharmaceuticals and oncology injectables, suggested that “it will be competitively priced.” Neupogen generated global sales of $1.2 billion last year, while Amgen filed a petition in February seeking to prevent Sandoz from launching its biosimilar version. A district court hearing on the case is scheduled for March 13.
Analysts at Barclays noted that “Neupogen already faces competition and sales erosion from Teva’s Granix (which though approved under the BLA pathway and technically a branded product, is essentially a biosimilar).” The analysts said “nevertheless, we believe it’s a matter of when, not if, [Sandoz’s] product will launch, and anticipate continued erosion of Neupogen over the foreseeable future.”
08- March – 2015