The course comes in response to changes in the way the US Food and Drug Administration (FDA) reviews and approves insulin products. In March 2020, insulin products in the US transitioned to a new regulatory pathway, allowing biosimilars to be developed. The change should make insulin products more available and affordable for American citizens [1].

The biosimilar insulin course is presented as a question and answer session with Professor Susan Cornell – author, clinical pharmacist, and certified diabetes care and education specialist (CDCES) – and discusses biosimilar insulins and what diabetes specialists need to know to prepare themselves to better manage persons with diabetes.

The course starts by saying that the change to the regulatory requirements ‘may drastically increase the number of biosimilar insulins available in the United States’.

It goes on to give a brief history of biosimilar insulins, pointing out that insulin is a large, complex, relatively unstable protein derived from living cells or organisms, and outlining the differences between generics and biosimilars.

There currently are no biosimilar insulins approved in the US, but there are four FDA-approved follow-on insulins. Admelog, Basaglar, Lusduna and PF708 were approved via the FDA’s abbreviated 505(b)(2) pathway as follow-on products not as biosimilars. No insulin lispro or glargine products were licensed under the Public Health Service Act at the time of filing, so there was no ‘reference product’ for a proposed biosimilar product [2].

The course goes on to discuss what to consider when using biosimilar insulin to manage blood glucose, and how educating individuals and caregivers is the key. Professor Cornell ends the course by saying that ‘Diabetes care and education specialists need to be aware of the nuances of using biosimilar insulins for diabetes management’. She demonstrates this by discussing two case studies that show the need to ‘add it all up for improved outcomes’.

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Biosimilars education still needed for US and EU clinicians

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA opens pathway to biosimilar insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 8]. Available from: www.gabionline.net/Guidelines/FDA-opens-pathway-to-biosimilar-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 May 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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