Semglee (insulin glargine-yfgn) was the first biosimilar to be granted interchangeable status by the US Food and Drug Administration (FDA) in July 2021 [1].

The biosimilar is made by US-based drugmaker Viatris (formerly Mylan) and partner, India-based biologicals specialist Biocon. The companies received approval from FDA for their insulin glargine biosimilar Semglee (MYL‑1501D) on 11 June 2020 [2].

Biocon and Viatris say that this decision ‘will help increase access to this critical treatment for millions of Americans living with diabetes’. They add that ‘broad coverage of Semglee by Express Scripts will help ensure that the many patients on its network who need insulin glargine may receive the full benefits of and access to treatment with lower or maintained out-of-pocket costs’.

Viatris commercializes Semglee injection in the US, which Biocon and Viatris call a ‘branded interchangeable biosimilar’, and Insulin Glargine (insulin glargine-yfgn) injection, an authorized interchangeable biosimilar. Both products will be available in pen and vial presentations and are interchangeable for the reference biological, Lantus. In addition, Semglee will also be included in Express Scripts’ Patient Assurance Program.

The companies state that ‘this dual product approach is intended to ensure that this historic interchangeable biosimilar insulin glargine can reach as many patients as possible regardless of financial circumstances, insurance or channel’.

Editor’s comment
Readers interested to learn more about biosimilars and interchangeability are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Interchangeability of biosimilars in the US and around the world

Interchangeability. An insurmountable fifth hurdle?

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Interactive map for interchangeable biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 5]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 5]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee

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