publication date: Dec. 19, 2014

ODAC To Advise FDA on First Biosimilars Application Jan. 7

 

The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim).

The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee.

The meeting will likely clarify the standards for approval of biosimilar biologics, which are likely to cost less than their branded counterparts.

The proposed indications for this product are:

• To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;

• For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia;

• To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation;

• For the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and

• For chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

The Affordable Care Act amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.

This pathway is provided in the part of the law known as … Continue reading 40-47 ODAC To Advise FDA on First Biosimilars Application Jan. 7

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