FDA accepts biosimilar filgrastim application

Biosimilars/News | Posted 01/08/2014 post-comment0 Post your comment

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 24 July 2014 that the US Food and Drug Administration (FDA) had accepted its application for approval of the company’s biosimilar filgrastim product.

G-CSF V13C08

Sandoz is the first company to announce it has filed for approval of a biological under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Sandoz already markets its biosimilar filgrastim product, under the brand name Zarzio, in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. Zarzio is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30% volume market share.

‘This filing acceptance represents a significant step toward making high quality biologic[al]s more accessible in the US’, according to Dr Mark McCamish, Head of Global Biopharmaceutical and Oncology Injectables Development at Sandoz.

Meanwhile, South Korean biotechnology company Celltrion has also been paving the way for submission of its infliximab biosimilar (Remsima) in the US. The company filed a lawsuit claiming that patents on originator drug Remicade (infliximab) are invalid and unenforceable [1]. Celltrion is anticipating submitting marketing authorization approval for Remsima in the US in the latter half of 2014.

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1. GaBI Online - Generics and Biosimilars Initiative. Celltrion files infliximab patent lawsuit in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-files-infliximab-patent-lawsuit-in-US

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Source: Sandoz

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