Chemically synthesized polypeptides to use biosimilars pathway

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Chemically synthesized polypeptides to use biosimilars pathway

INICIO/Políticas y legislación | Posted 31/01/2020 0 Post your comment

The US Food and Drug Administration (FDA) is supporting a change in the government spending bill that will allow for chemically synthesized polypeptides to also be classified as biologicals.

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’.

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: US FDA