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Comments criticize FDA guidance on insulin biosimilars Posted 20/03/2020

Eli Lilly and Novo Nordisk have submitted critical comments on the US Food and Drug Administration’s (FDA) draft guidance on insulin biosimilars, which suggests that immunogenicity testing may not be necessary for all products.

Insulin prices in the US have long been an issue, available at such an expense they are unaffordable for many patients [1]. FDA has been taking various actions to combat this and promote biosimilar insulin development.

Draft guidance issued by FDA in November 2019 [2] outlined immunogenicity considerations for insulin biosimilars. The guidance stated that such biosimilars may not need to undergo comparative clinical immunogenicity studies, if a comparative analytical assessment demonstrates that the products are ‘highly similar’.

This is similar to the situation in Europe, where the European Medicines Agency (EMA) does not require clinical immunogenicity studies for all biosimilars [3].

However, comments submitted in January by Eli Lilly and Novo Nordisk are critical of the FDA’s guidance.

Eli Lilly suggested that FDA should revise the guidance to clarify which biosimilars immunogenicity testing is required for. ‘Should FDA intend to apply the Draft Guidance to insulin products which were not approved under a section 505(b)(2) application, Lilly believes that good science dictates some amount of clinical immunogenicity data should be required in order to understand the impact of potential differences in immunogenicity profiles on clinical outcomes.’

The company also rejected the idea that insulin biosimilars be approved as interchangeable products. ‘Although presentation considerations are important for biosimilarity assessments, FDA should pay particular attention to the insulin products presentations in the interchangeability context. There, by virtue of automatic substitution based on an interchangeability designation, a patient could be confronted with an unfamiliar presentation without the benefit of prescriber oversight or additional training’, they commented.

Novo Nordisk added that it experienced ‘unexpected immunogenicity’ in response to a new insulin analogue encountered during its clinical development.

The company said this represents the ‘unpredictable nature’ of immunogenic reactions to insulin formulations and advised caution regarding the FDA’s assumption that ‘if a comparative analytical assessment based on state-of-the-art technology supports a demonstration of ‘highly similar’ for a proposed biosimilar or interchangeable insulin product, there would be little or no residual uncertainty regarding immunogenicity’.

Both Eli Lilly and Novo Nordisk have launched biosimilar versions of their own insulin products [4, 5]. However, they are also facing competition from other manufacturers, such as Lannett [6].

Sanofi, the third originator insulin manufacturer in the US, did not submit any comments on the guidance.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Senior US senator calls on insulin manufacturers to justify high prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Generics/General/Senior-US-senator-calls-on-insulin-manufacturers-to-justify-high-prices
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for insulin biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-insulin-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EMA issues finalized insulin biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Guidelines/EMA-issues-finalized-insulin-biosimilars-guideline
4. GaBI Online - Generics and Biosimilars Initiative. Eli Lilly launches lower-priced insulin lispro [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Eli-Lilly-launches-lower-priced-insulin-lispro
5. GaBI Online - Generics and Biosimilars Initiative. Novo Nordisk to launch biosimilar insulin in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/General/Novo-Nordisk-to-launch-biosimilar-insulin-in-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Positive trial results for Lannett’s insulin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/Research/Positive-trial-results-for-Lannett-s-insulin-biosimilar

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Source: EMA, Novo Nordisk

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