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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