For historical reasons insulin products were previously approved under the Food, Drug, and Cosmetic Act (FD&C Act) of the Public Health Service Act as drugs. However, from March 2020 they will be deemed to be biologicals [1]. This opens up the biosimilar pathway – Biologics Price Competition and Innovation Act of 2009 (BPCI Act) to biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, an FDA-licensed biological product [2].

However, ‘chemically synthesized polypeptides’, for example, a chemically synthesized copy of a protein product, e.g. an insulin copy, were excluded from this transition. This means that a product that falls within this category would not be able to come to market as a biosimilar or interchangeable product, or through the generic drug pathway, but would have to use the new drug application (NDA) route, which could be much more resource-intensive and therefore expensive.

However, a small change in the soon-to-be passed government spending bill will now allow for chemically synthesized polypeptides to be included in the NDA to biologic license application (BLA) switch that will occur in March 2020. This change, according to FDA, will expand access to these products and increase competition.

The agency, in a statement made on 17 December 2019, said that ‘in addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes’.

Related article
FDA issues draft guidance for insulin biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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