FDA to hold public meeting on access to affordable insulin

Biosimilars/General | Posted 26/04/2019 post-comment0 Post your comment

The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.

Review committee V15a16

FDA is soliciting input on steps the agency can take to facilitate increased access to insulin products, including biosimilar and interchangeable insulin products. The agency is interested in how it can encourage the development of biosimilar and interchangeable insulin products, while achieving the balance between competition and innovation intended by Congress in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

In a Federal Register notice published on 3 April 2019 FDA announced that it will hold a public meeting on 13 May 2019 at the agency’s White Oak Campus, New Hampshire, USA to discuss increasing access and facilitating the efficient development of biosimilar and interchangeable insulin products.

According to FDA, access to insulin can be increasingly difficult for diabetics in America. The agency notes that ‘insulin list prices regularly increase by double digits annually’ and that ‘these increases have raised serious concerns about the ability for many patients to access the insulin needed to survive’. The agency says that, while it accepts that ‘driving down drug prices requires a comprehensive approach’, it also believes that ‘one impactful route is through competition’, which is where biosimilar and interchangeable insulin products come into the picture.

At the meeting in May 2019, FDA is seeking input from patients, families, healthcare providers, and other stakeholders who live with diabetes or care for someone with diabetes, as well as manufacturers and other stakeholders.

Three follow-on insulin products (Admelog, Basaglar and Lusduna) have been approved in the US. However, to date, no biosimilar or interchangeable insulin product has been approved in the country [1].

This public hearing is part of FDA's broader effort to facilitate the growth of a competitive market for biologicals. In July 2018, FDA issued its Biosimilars Action Plan, which aims to improve the efficiency of the biosimilar and interchangeable product development and approval process [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases guidances and proposed rule to advance biosimilars policy framework [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Guidelines/FDA-releases-guidances-and-proposed-rule-to-advance-biosimilars-policy-framework

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Source: Federal Register, US FDA

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