Although Mylan and partner Biocon did not beat the March 22, 2020 deadline for the transition of new insulins to biosimilar status, they were able to secure a 505(b)2 FDA approval for their insulin glargine follow-on agent.
On June 11, the partners announced receiving FDA approval for Semglee™. Technically, Semglee has the same amino acid sequence, and provides outcomes that are not significantly different than that for Sanofi’s originator agent Lantus®. However, insulins were not subject to the biosimilar approval pathway until the designated transition date of March 22, 2020 (which was extended in the case of Mylan and Biocon’s product through legislative action). The second FDA decision in September 2019 resulted in a complete response letter related to plant deficiencies. An initial FDA decision in 2018 also did not result in licensing authorization.
Extending the deadline spared the partners having to reapply for approval under the 351(k) biosimilar pathway, citing Lantus as the reference agent. This would have delayed another FDA decision by perhaps 18 months or more. The other US marketed insulin follow-on products—Basaglar® and Admelog®—were approved like Semglee, under the 351(a) pathway. Whereas Basaglar is a glargine follow-on product, Admelog is a lispro follow-on agent.
The approval was supported by two phase 3 studies (INSTRIDE-1 and INSTRIDE-2), which demonstrated that Semglee had no significant differences in terms of safety, efficacy, and immunogenicity compared with Lantus.
In the press release, Mylan President Rajiv Malik stated, “Today’s milestone makes Mylan the first company to have approvals on both the vial and pen presentations of insulin glargine treatment options to Lantus.”