New insulin glargine and potential adalimumab interchangeable biosimilars

Biosimilars/News | Posted 27/01/2023 post-comment

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The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.

Interchangeable insulin glargine
Eli Lilly’s Rezvoglar was the second insulin glargine biosimilar to be approved in the US [1]. The first insulin glargine biosimilar, Viatris and Biocon’s Semglee, was approved in June 2020 [2] and was the first biosimilar to be given interchangeable status in July 2021 [3]. Insulin glargine is a long-acting human insulin analogue indicated to improve glycaemic control in adults and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus [1].

FDA awarded the interchangeable status to Rezvoglar without the need for new clinical data, comparative clinical immunogenicity study nor a switching study, to be submitted to support the interchangeable tag.

Potential interchangeable adalimumab biosimilar
At the November 2022 American College of Rheumatology’s annual meeting, results related to Pfizer's biosimilar (adalimumab-afzb) were presented. These showed that the biosimilar was essentially identical to AbbVie's original version for every pharmacokinetic parameter analysed, including maximum and trough concentrations, average concentration, time to reach maximum concentration, total drug exposure over time, and others. Immunogenicity markers and adverse events profiles were also highly similar. It was noted that this is the first interchangeability study of an adalimumab biosimilar to be conducted in rheumatoid arthritis patients.

If it achieves interchangeable status, Pfizer’s biosimilar adalimumab will join Cyltezo the second biosimilar to be given interchangeable status in October 2021, as a second approved interchangeable adalimumab biosimilar [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-and-insulin-glargine-biosimilars-yusimry-and-rezvoglar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo as interchangable [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-biosimilar-cyltezo-as-interchangeable

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