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.

Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015 [1].

To date, FDA has approved 56 biosimilars within the product classes of: 1) insulin; 2) granulocyte colony-stimulating factor; 3) monoclonal antibodies and 4) tumour necrosis factor-alpha (TNF-α), 5) vascular endothelial growth factor (VEGF) inhibitor, as shown in see Table 1.

Of these, 13 are approved as interchangeable biosimilars, as shown in Table 2. Table 3 presents the follow-on biologicals approved by the FDA.

In the FDA approval of biosimilars, infliximab-dyyb was approved under two brand names: Inflectra (Pfizer) in 2016 and Zymfentra (Celltrion) in 2023. On 5 March 2024, denosumab-bddz from Sandoz was approved under two brand names: Jubbonti and Wyost.

Table 2 details the total number of biosimilars and interchangeable biosimilars approved by the FDA since 2017. The 13 interchangeable biosimilars approved are: Abrilada (adalimumab-afzb); Byooviz (ranibizumab-runa); Cimerli (ranibizumab-eqrn); Cyltezo (adalimumab-adbm); Jubbonti (denosumab-bddz); Opuviz (aflibercept-yszy); Rezvoglar (insulin glargine-aglr); Semglee (insulin glargine-yfgn); Simlandi (adalimumab-ryvk); Wezlana (ustekinumab-auub); Wyost (denosumab-bddz), Yesafili (aflibercept-jbvf). The FDA granted provisional determination for interchangeability designation for Pyzchiva [2].

FDA has approved six follow-on biologicals in the product classes of enoxaparin sodium (Enoxaparin sodium and M-Enoxaparin); insulin (Admelog, Basaglar and Lusduna) and teriparatide (PF708), see Table 3. The approval for one insulin glargine (Lusduna) and teriparatide follow-on biological (PF708) are tentative pending patent litigation.

As of the end of July 2024, the FDA has approved a total of 58 biosimilars, including six follow-on biologicals that did not undergo the BLA 351K process for use in the US.

Two somatropins – Omnitrope (Sandoz) and Valtropin (LG Life Sciences, Biopartners) – have been approved by FDA in 2007 as a follow-on protein product. Omnitrope is being marketed in the US since 2007 for GHD in children and adults.

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].

Most of 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 that include a 4-digit random suffix, for all of the biosimilars that it has approved to date. The agency issued final guidance on the naming of biologicals in January 2017 [5].

FDA made a landmark decision on 28 July 2021 to approve the insulin glargine biosimilar Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product approved in the US for the treatment of diabetes [6].

Related articles
Biosimilars approved in Europe

US guidelines for biosimilars

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 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-ustekinumab-biosimilar-pyzchiva
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 
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 1]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals

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