These injections will aid control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. The currently marketed non-interchangeable Semglee is anticipated to be phased out by the end of the 2021 calendar year.
Shreehas Tambe, deputy CEO of Biocon Biologics, said: “This is indeed a landmark event and along with the recent formulary listings, we believe it will allow us to improve accessibility, availability and adoption of biosimilars in the US for the benefit of patients and the overall healthcare system.”
In July 2021, biosimilar Insulin Glargine received a historic US approval as the first interchangeable biosimilar under the 351(k) regulatory pathway. Semglee and biosimilar Glargine were approved by the USFDA in July 2020 and commercialised in the US market by r Viatris last year. T
The interchangeable designation for Semglee will allow pharmacists to substitute it for its brand name reference product Lantus without the permission of the original prescribing physician, much like generic drugs.
Semglee, with the interchangeability label, will now be commercialised by Viatris in the US by the end of this calendar year. Viatris is eligible for a 12-month exclusivity period from the date of commercial launch before the USFDA can approve another interchangeable biosimilar glargine.
 "Biocon Biologics")