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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.