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FDA opens pathway to biosimilar insulin products Posted 03/04/2020

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.

The change dates back to the 2009 Biologics Price Competition and Innovation Act (BPCI Act), which created a 10-year timeline for the transition of biologicals that were historically regulated under the Food, Drug and Cosmetic (FD&C) Act.

The BPCI Act created an abbreviated pathway under the Public Health Service Act (PHS Act) for biologicals shown to be biosimilar or interchangeable with an FDA-approved biological.

Under the Act, as of 23 March 2020, the subset of biologicals approved under the FD&C Act (which includes insulin) transition to being regulated as biologicals, allowing the abbreviated licensure pathway to be used [1].

It has previously been difficult to develop biosimilars of these drugs under FD&C Act due to ‘scientific challenges’ and ‘limitations on the scope of data that can be relied upon in a generic drug application’, says the US Food and Drug Administration (FDA). As a result, there has been limited competition in the market for these drugs and therefore higher prices.

Now, insulin and some other biologicals, e.g. human growth hormone, pancrelipase, chorionic gonadotropin, follitropin alfa and menotropins, will be open to competition from biosimilars, or interchangeable biologicals, which have been defined by FDA as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’ [2].

It is hoped that this regulatory change will increase patient access and reduce costs for insulin therapies, which have been notoriously high in the US [3]. Even having one generic drug on the market can reduce prices by 31%–39%, and biosimilars typically launch with initial list prices 15%–35% lower than the reference drug.

FDA’s Center for Drug Evaluation and Research Director Janet Woodcock said in a statement: ‘Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications’.

The agency recently released guidance on immunogenicity considerations for biosimilar and interchangeable insulin products, indicating that immunogenicity tests may not be necessary if a comparative analytical assessment demonstrates that the products are ‘highly similar’ [4], which was soon criticized by brand-name insulin manufacturers Eli Lilly and Novo Nordisk [5].

Related articles
FDA issues new rule on definition of term ‘biological product’

FDA issues final guidance on interchangeable biologicals

Biosimilars approved in the US

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 Apr 3]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/FDA-releases-new-information-on-interchangeable-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Reasons and solutions for the high cost of insulin in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/Research/Reasons-and-solutions-for-the-high-cost-of-insulin-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for insulin biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-insulin-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Comments criticize FDA guidance on insulin biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Guidelines/Comments-criticize-FDA-guidance-on-insulin-biosimilars

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Source: US FDA

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