A joint press release from Mylan and Revance issued on June 1, 2020 stated that progress is being made on characterizing a proposed Botox biosimilar. As a result, Mylan has agreed that the onabotulinumtoxinA biosimilar development program should proceed.
According to the press release, the partners engaged the Food and Drug Administration to discuss the possibility of an onabotulinumtoxinA biosimilar in early 2019. Based on the positive results of that meeting, Mylan and Revance took their analytical and characterization program to the next level, which would await Mylan’s decision to proceed. Specific developmental milestones have been passed, and Mylan has paid Revance based on its existing agreement.
A fascinating aspect of this biosimilar news is that Revance has been focused on a novel botulinum toxin A agent called daxibotulinumtoxinA, which has undergone more than a dozen studies for primarily cosmetic uses. The development of a biosimilar version of Botox could compete directly with this follow-on agent. Revance had filed for 351(a) approval from the FDA drug in February 2020 for daxibotulinumtoxinA.
Not only is Allergan’s Botox indicated for cosmetic uses, but this reference agent is approved for use in muscle spasticity, migraine prevention, overactive bladder, and other disorders (several of which are potential targets of daxibotulinumtoxinA).
In other biosimilar news… Fresenius Kabi announced its first FDA-accepted 351(k) submission—for MSB11455, a version of pegfilgrastim. It is likely the application package includes data from two phase 1 clinical trials (in healthy subjects) to test the safety and pharmacokinetics/pharmacodynamics of MSB11455. Based on a May 27 submission date, Frenenius Kabi should expect an FDA decision in Q2 2021.