Semglee, first-of-its-kind insulin product made by India’s Biocon, gets US approval
The US Food and Drug Administration (FDA) approved a biosimilar interchangeable insulin product Wednesday, for treatment of diabetes, for the first time in the country.
Semglee, manufactured by Biocon Biologics, a Bengaluru-based pharmaceutical company, is both interchangeable with and biosimilar to Lantus, a long-acting insulin product already approved in the US.
Biosimilar products have no clinically meaningful difference from reference products (in this case Lantus) that have already been approved in market. An interchangeable biosimilar product, meanwhile, means the drug could be used as an alternative by patients without the intervention of a prescriber. It is similar to buying a different brand of the same medicine.
According to the FDA, one can expect the same safety and effectiveness from a biosimilar product, as from the reference product, and the newly approved drug will be as effective in tackling diabetes as insulin is.
“The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness),” noted a statement by FDA.