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

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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

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