The USA has moved closer to getting its first biosimilar after a Food and Drug Administration panel unanimously backed Novartis unit Sandoz’ version of Amgen’s Neupogen.
Neupogen (filgrastim), a man-made version of granulocyte-colony stimulating factor, is used to treat neutropenia which can result from chemotherapy. The FDA’s Oncologic Drugs Advisory Committee has voted 14-0 in favour of recommending the Sandoz version, to be marketed as Zarxio, for approval.
The committee’s recommendation is based on review of extensive data presented by Sandoz, including post-marketing studies – the biosimilar is already sold in more than 40 countries outside the USA (including Europe) as Zarzio. The FDA panel decided that the drug is “highly similar” to Neupogen i.e. that there are no clinically meaningful differences between the treatments.
Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said the firm believes “this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the USA”. The committee recommended approval of Zarxio for use in all five indications included on the Neupogen label.
Zarxio is therefore set to be the first biosimilar approved in the USA and has caused a stir. Before the vote was known, Generic Pharmaceutical Association (GPhA) chief executive Ralph Neas said the ODAC meeting “features a strong showing of science-based support” for biosimilars, saying it is “an important step forward for cancer patients and all who are awaiting access to more affordable versions of lifesaving biologics”.
