Last update: 14 August 2015
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a Food and Drug Administration (FDA)-licensed biological product.
FDA is still in the process of developing guidelines regarding these types of products, although to date, it has issued six draft guidance documents for public comment .
Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015 . To date, FDA has approved one biosimilar within the product class of granulocyte colony-stimulating factor for use in the US, see Table 1.
Table 1: FDA approved biosimilars*
|Product name||Active substance||Therapeutic area||Authorization date||Manufacturer/ Company name|
|Zarxio||filgrastim||Autologous peripheral blood progenitor cell collection and therapy Bone marrow transplantation Cancer Myeloid leukaemia Neutropenia||6 Mar 2015||Sandoz|
*Data collected on 14 August 2015.
The landmark decision by FDA to approve its first biosimilar came in the wake of a unanimous vote two months earlier by FDA advisors who recommended approval of Zarxio . Sandoz, the generics division of Novartis, already markets its biosimilar filgrastim product under the brand name Zarzio in more than 40 countries outside the US .
Zarxio has been approved as a biosimilar, not as an interchangeable product. According to the BPCI Act, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
FDA has also designated a placeholder non-proprietary name for the biosimilar – filgrastim-sndz. The agency has, however, made it clear that it has not yet made a final decision on whether biosimilars will receive the same International Nonproprietary Name (INN) as their reference biologicals or unique names.
- GaBI Online – Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
- GaBI Online – Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
- GaBI Online – Generics and Biosimilars Initiative. FDA advisers recommend approval of filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-filgrastim-biosimilar
- GaBI Online – Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application
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