The evolution of biosimilars in the US Posted 07/04/2017

The US has come a long way since the introduction of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was signed into law on 23 March 2010 by President Barack Obama.

It has, however, been rather slow on the biosimilars front. In the European Union (EU), a legal framework for approving biosimilars was established in 2003 and biosimilars have been approved by the European Medicines Agency (EMA) since 2006. There are currently 29 biosimilars approved in Europe [1].

In contrast, as of November 2016, the US Food and Drug Administration (FDA) had only approved four biosimilars [2] and had seven active biosimilar filings pending review [3].

In fact, legislation to allow the approval of biosimilars was only introduced in the US in 2009, see Figure 1.

Figure 1: Evolution of biosimilars in the US

CMS: Centers for Medicare & Medicaid Services; FDA: US Food and Drug Administration.

Despite the introduction of legislation allowing for an abbreviated pathway for biosimilars in the US, FDA only finalized its overarching guidelines on biosimilars in April 2015 [4]. This was after the first biosimilar (filgrastim-sndz) had been approved in the country.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. Jordan B. Regulatory implications for implementing biosimilar interchangeability: addressing policy and practical concerns. SMi 3rd Annual Biosimilars North America Conference; 16−17 November 2016, Iselin, New Jersey, USA.
4. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars

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