The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.

Although Mylan has yet to announce specific launch plans for its long-acting injectable product referencing Sanofi’s blockbuster, Lantus, the Hertfordshire, U.K., company said a few weeks ago it was prepared to bring Semglee to the market as soon as possible following FDA approval.

That announcement came on the heels of a U.S. Patent and Trademark Appeal Board (PTAB) decision that found all the Lantus Solostar device patent claims that Mylan challenged in inter partes reviews were unpatentable. Even had the PTAB ruled otherwise, Mylan said it was prepared to launch as soon as Semglee was approved, as it had obtained a covenant from Sanofi not to sue on the '008 patent.

Aside from patent issues, the approval path for Semglee has been a bit of a rollercoaster due to regulatory uncertainties introduced by the Biologic Price Competition and Improvement Act (BPCIA), which mandated that insulin and other small proteins approved as new drug applications (NDAs) be deemed as biologic license applications (BLAs) March 23, 2020.

In a 2016 guidance on how it would make the transition, the FDA said the NDA route would be closed to proteins after March 23, 2020 – even if their applications were still pending at the time. It also said it wouldn’t approve pending or tentatively approved 505(b)(2) applications listing an approved NDA that had been deemed a BLA. It looked like Semglee, initially filed as a 505(b)(2), could be caught in that trap.

Fortunately for Mylan and other sponsors with insulin follow-ons in the works, Congress forced the FDA to change its tune just a few months before the deeming deadline. The 2020 spending bill required the FDA to continue its review of 505(b)(2) and 505(j) applications after the deeming deadline, so long as they were submitted by March 23, 2019. If those applications were approved after March 23, 2020, they were to be deemed BLAs.

Consequently, Semglee was approved Thursday as a “new” BLA, even though it started out as a follow-on referencing Lantus through the 505(b)(2) path. Thus, it can serve – along with Sanofi’s drug and Lilly’s Basaglar, which was approved as a 505(b)(2) drug in 2015 – as a reference drug for future insulin glargine biosimilars and interchangeables.

Once available, “biosimilar and interchangeable insulin products are expected to expand competition and ultimately empower patients by increasing choices and potentially lowering prices,” the FDA said in announcing Semglee’s approval. The question is when that will be. Before the March 23 deeming day, the FDA's Janet Woodcock said there already was a robust pipeline and a lot of interest in developing insulin biosimilars.

Insulin also is expected to be the first proving ground for generic-like competition from interchangeables. Unlike current biologics referenced by biosimilars that are administered by doctors, insulin products are dispensed at the pharmacy, which opens the door to the BPCIA path that allows an interchangeable to be automatically substituted at the pharmacy when its reference biologic is prescribed.

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