In a landmark decision, the US Food and Drug Administration (FDA) has approved its first interchangeable biosimilar.
The agency announced on 28 July 2021 that it had approved insulin glargine biosimilar Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product approved in the US for the treatment of diabetes.
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 .
This new ‘interchangeable’ status means that Semglee may now be substituted for the reference product (Sanofi’s Lantus) without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called ‘pharmacy-level substitution’ – much like how generics are substituted for brand-name drugs, subject to state pharmacy laws, which vary by state .
Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.
More than 34 million people in the US today have been diagnosed with diabetes. The FDA’s Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, Dr Peter Stein, says that ‘access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of type 1 and 2 diabetes mellitus’.
Acting FDA Commissioner Dr Janet Woodcock, added that ‘this is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce healthcare costs’. She also said that this approval is part of the agency’s ‘longstanding commitment to support a competitive marketplace for biological products’.
Readers interested to learn more about interchangeability in the US are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Interchangeability. An insurmountable fifth hurdle?
Interchangeability of biosimilars in the US and around the world
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Biosimilars policy considerations in the US
FDA releases new information on interchangeable biologicals
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1. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
2. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws
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Source: Biocon, US FDA, Viatris