12:00 AM
Jan 12, 2015
 |  BioCentury  |  Regulation

Advising the advisors

FDA instructs panel to review first biosimilar on totality of evidence

FDA used last week's panel review of Zarxio, a G-CSF product from the Sandoz unit of Novartis AG, to instruct the public, the Oncologic Drugs Advisory Committee and other committees on how to consider the data packages for biosimilars. In addition to educating the panel, the review of the first-ever biosimilars application provided a concrete example of how the agency and ODAC view extrapolation of clinical data for biosimilars, at least for a product that has been marketed for several years in Europe.

Sandoz is seeking approval for Zarxio as a biosimilar of Amgen Inc.'s Neupogen filgrastim, including all five indications for which Neupogen is approved: to treat cancer patients receiving myelosuppressive chemotherapy; patients with acute myelogenous leukemia (AML) receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients undergoing peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

While Sandoz conducted a clinical trial in only one of Neupogen's approved indications, FDA reviewers found the total data package sufficient to recommend approval as a biosimilar for all five indications, and ODAC unanimously agreed.

Zarxio's case was helped by its history of use in other countries, which Sandoz said amounted to over 7.5 million days of patient exposure. EMA approved the product in 2009 under the brand name Zarzio for all indications for which Neupogen is approved.

The agency did not reveal its thinking - or ask for the panel's advice - on the outstanding issues of non-proprietary naming or interchangeability.

But FDA will have to decide on the former before it approves Zarxio. The user fee goal is March 8.

The agency does not have to address interchangeability to approve the product. Sandoz did not seek a designation of interchangeability in its submission, even though the package included data from patients who switched between Zarxio and Neupogen - which FDA has...

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