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[27] [91] In July 2021, the US Food and Drug Administration (FDA) approved an interchangeable biosimilar insulin product, Semglee (insulin glargine-yfgn), for the treatment of diabetes. [14] Unbranded versions of insulin glargine and insulin glargine-yfgn are sold by Sanofi [92] and Viatris. [20]
In a previous review it was unclear if there is a difference in hypoglycemia, as there was not enough data to determine any differences with respect to long term outcomes, [15] however a more recent Cochrane systematic review did not find clinically significant difference when comparing insulin glargine to NPH insulin, insulin detemir or ...
Insulin is regulated as a biologic rather than as a drug. [103] The changed status gives the FDA more flexibility for approval and labeling. [104] In July 2021, the FDA approved insulin glargine-yfgn (Semglee), a biosimilar product that contains the long acting analog insulin glargine. [105]
Insulin glargine/lixisenatide, sold under the brand name Soliqua among others, is a fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes. The most common side effects include hypoglycemia (low blood glucose), diarrhea, vomiting and nausea (feeling sick).
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The onset of action of subcutaneous insulin glargine is somewhat slower than NPH human insulin. It is clear solution as there is no zinc in formula. [9] [better source needed] The biosimilar insulin glargine-yfgn (Semglee) was approved for medical use in the United States in July 2021, [10] and in the European Union in March 2018. [11]
In 2021 Biocon and Viatris received approval to launch Semglee, an insulin glargine-yfgn injection, which is the first interchangble biosimilar for diabetes in the United States. [42] In 2021, Biocon sold 15% of Biocon Biologics to Serum Institute of India for a valuation of $4.9 billion, for which Biocon will receive access to 100 million ...
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