FDA advisers recommend approval of filgrastim biosimilar

Biosimilars/News | Posted 09/01/2015 post-comment0 Post your comment

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex biological therapies more readily accessible in the US.

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Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

At their meeting on 7 January 2015, advisers from FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14–0 in favour of the recommendation to approve Sandoz’s filgrastim biosimilar in all five indications of the originator product (Neupogen).

The decision was based on nonclinical, clinical and post-marketing pharmacovigilance data which confirmed Sandoz’s biosimilar filgrastim to be ‘highly similar’ to the reference product (Amgen’s Neupogen).

FDA accepted Sandoz’s application for marketing approval of its filgrastim biosimilar in July 2014, as the first biological application to be accepted via the abbreviated biosimilars pathway in the US [1].

Although FDA is not obliged to follow the recommendations of its advisers, it commonly does, and the agency is expected to make a final decision in the coming months.

Sandoz, which is the generics division of Swiss drug giant Novartis, already markets its biosimilar filgrastim product, under the brand name Zarzio, in more than 40 countries outside the US [1].

Neupogen generated an estimated US$1.2 billion in sales for Amgen in 2014. If approved in the US, Sandoz proposes to market its biosimilar filgrastim under the brand name Zarxio.

In the wake of this news the Biotechnology Industry Organization (BIO) has urged FDA to release final guidance on processes and scientific criteria for the approval of biosimilars. While both BIO and the GPhA have called on FDA to outline its approach to naming and labelling and to clarify its conditions for determining a biosimilar to be interchangeable with its reference biological.

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application 

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Source: BIO,FDA, GPhA, Sandoz

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