The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1]. But how will biosimilars be classified in the future and how will savings for biosimilars be realized in the US? These are questions Sarpatwari and co-authors sought to answer [2].
Despite the fact that biologicals in the US account for less than 1% of prescriptions, they account for 28% of prescription drug spending. Their high cost has resulted in healthcare providers either imposing high co-payments on patients or refusing to cover the drugs at all. Neither of which is ideal for patients.
However, many of the biologicals in question, such as Amgen’s cancer blockbuster Neupogen (filgrastim), have been on the market for many years and have patents that have expired some years ago [3]. Thus, enter the biosimilars.
An abbreviated pathway for approval of biosimilars was created by the Biologics Price Competition and Innovation Act of 2009. This pathway allows for two types of biosimilars to be approved: products with no meaningful differences to the reference product, and interchangeable biosimilars that can be safely substituted for the originator product. Interchangeability is a higher regulatory standard that still requires clarification from FDA. Therefore, current products under review by FDA are expected to be approved as just biosimilars – without the interchangeable designation – as was the case for Zarxio.
FDA is currently reviewing versions of epoetin alfa (Epogen, 1989) [4], filgrastim (Neupogen, first approved in 1991) [5], infliximab (Remicade, 1998) [6] and pegfilgrastim (Neulasta, 2002) [5].
But how will US post-approval requirements and exclusivity periods, among other factors, hinder the uptake of biosimilars and reduce possible cost savings to be made with these products? These issues are discussed in following series of two articles.
Related Articles
Biosimilars in the US: hurdles to cost savings
Overcoming hurdles to biosimilars cost savings in the US
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. Sarpatwari A, Avorn J, Kesselheim AS. Progress and hurdles for follow-on biologics. N Engl J Med. 2015 May 6. doi:10.1056/NEJMp1504672
3. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
4. GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Second Apotex biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/Second-Apotex-biosimilar-under-FDA-review
6. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
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