Biosimilars in the US: hurdles to cost savings

Biosimilars/Research | Posted 07/08/2015 post-comment0 Post your comment

In light of the recent approval of the first biosimilar in the US, Zarxio (filgrastim-sndz), [1], Sarpatwari and co-authors look at the hurdles to cost savings for biosimilars in the US [2].

Pay for Delay DrugsMoneyGeneric V13F21

The introduction of generics of small-molecule drugs can reduce prices by 90% from the brand-name version, which has saved US consumers more than US$1.5 trillion over the past decade. However, according to the US Food and Drug Administration (FDA), the maximum cost savings are only achieved when 10 or more competitors are on the market. This situation is unlikely to occur with biosimilars, due to their complexity, meaning that only a limited number of players are capable of manufacturing such products.

In the European Union, where 19 biosimilars are currently approved for use [3], the median price savings for biosimilar epoetin alfa is just 35%. However, recent mega-price cuts on biosimilar infliximab in Norway could mean that the tide is turning [4].

The authors believe savings from biosimilars may be less than expected in the US due to hurdles such as:

  • the patent-dispute resolution process under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009
  • longer exclusivity: 12-year exclusivity for biosimilars compared to 5 years for generics
  • requirement for vigorous post-approval surveillance of all biologicals
  • naming requirements: whereas the European Medicines Agency permits biosimilars to use the same active ingredient name as their brand-name counterparts, US naming practices for these products are not set
  • state legislation, which may hinder substitution and reduce market penetration

Related article
Biosimilars in the US

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 Aug 7]. 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. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Huge discount on biosimilar infliximab in Norway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 7]. Available from: www.gabionline.net/Biosimilars/General/Huge-discount-on-biosimilar-infliximab-in-Norway

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.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010