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 US Food and Drug Administration (FDA)-licensed biological product.

FDA is still in the process of developing guidelines regarding these types of products and has issued several guidance documents on the subject [1].

Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015 [2]. To date, FDA has approved 12 biosimilars within the product classes of anti-tumour necrosis factor-alpha (TNF-α), HER2/neu and granulocyte colony-stimulating factor, and two follow-on biologicals in the product class of insulin for use in the US, see Table 1. The agency has also granted tentative approval to an insulin glargine follow-on biological, pending patent litigation.

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 [3]. 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 [4].

All the products approved so far have been approved as biosimilars, not as interchangeable products. 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 designated placeholder non-proprietary names for Amjevita, Cyltezo, Erelzi, Fulphila, Inflectra, Ixifi, Mvasi, Nivestym, Ogivri, Renflexis, Retacrit and Zarxio: adalimumab‑atto, adalimumab‑adbm, etanercept‑szzs, pegfilgrastim-jmdb, infliximab‑dyyb, infliximab-qbtx, bevacizumab-awwb, filgrastim-affi, trastuzumab-dkst, infliximab-abda, epoetin alfa-epbx and filgrastim‑sndz, respectively. The agency issued final guidance on the naming of biologicals in January 2017 [5].

Related articles
Biosimilars approved in Europe

US guidelines for biosimilars

References
1.   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
2.   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
3.   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
4. 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
5.   GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 9]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals 

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