The US has entered a new era in medicines with the historic launch of the country’s first biosimilar. Sandoz, the generics division of Novartis, announced on 3 September 2015 that it had launched its filgrastim biosimilar, Zarxio (filgrastim-sndz), in the US.
The launch follows news that Amgen’s appeal against the rejection of its request for a preliminary injunction blocking Sandoz from launching Zarxio was also rejected [1].
Sandoz gained approval for Zarxio on 6 March 2015 from the US Food and Drug Administration in all five indications of Amgen’s originator product (Neupogen) [2]. The drug was the first product approved in the US as a biosimilar using the abbreviated pathway made possible by the Biologics Price Competition and Innovation Act of 2009.
Filgrastim is a granulocyte colony-stimulating factor used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.
Despite the fact that biologicals in the US account for less than 1% of prescriptions, they account for 28% of prescription drug spending [3]. Their high cost has resulted in healthcare providers either imposing high copayments on patients or refusing to cover the drugs at all. Neither of which is ideal for patients.
Mr Richard Francis, Global Head, Sandoz said Zarxio would increase access to this important cancer treatment by offering a ‘high quality, more affordable version’. While Dr Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders and Chief Medical Officer for the International Oncology Network (ION) added that the reduced cost of biosimilars could ‘help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies’.
Sandoz has not yet stated how much it intends to charge for its filgrastim biosimilar. However, in Europe, where biosimilars have been on the market since 2006, the median price savings for biosimilar epoetin alfa is 35% [4]. However, recent price cuts on biosimilar infliximab in Norway of a staggering 72% [5] and in France of 45% [6] could mean that the tide is turning.
Neupogen generated an estimated US$1.2 billion in sales for Amgen in 2014.
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References
1. GaBI Online - Generics and Biosimilars Initiative. US court rejects Amgen’s bid to block filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/US-court-rejects-Amgen-s-bid-to-block-filgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in the US: hurdles to cost savings [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-in-the-US-hurdles-to-cost-savings
5. GaBI Online - Generics and Biosimilars Initiative. Huge discount on biosimilar infliximab in Norway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/Huge-discount-on-biosimilar-infliximab-in-Norway
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab offered to French hospitals at 45% discount [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-offered-to-French-hospitals-at-45-discount
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