Revance, Mylan to File Application for Botox Biosimilar

Revance and Mylan have decided to move forward with an application for FDA approval of an onabotulinumtoxinA (Botox) biosimilar, which they said would potentially be the first Botox biosimilar.

“This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline,” said Mylan President Rajiv Malik in a statement.

The emphasis on therapeutic categories suggests that the biosimilar may compete with another product Revance has in development, daxibotulinumtoxinA, a novel botulinum toxin type A that the company also hopes will compete with the Botox reference product.

351(k) Pathway Is Acceptable

Mylan and Revance said their decision is based on feedback from the FDA indicating that the 351(k) pathway for biosimilar approval under the Public Health Service Act would be appropriate for this product candidate.

The 351(k) pathway allows for licensure “based on less than a full compliment of product specific preclinical and clinical data.” In other words, it’s an abbreviated licensure pathway that does not require a biosimilar company to duplicate all of the work done by the product originator company in order to obtain FDA approval.

The plan for an onabotulinumtoxinA biosimilar stems from a collaboration and license agreement signed by the 2 companies in February 2018 for development, regulatory approval, and commercialization of the product.

Revance is now eligible to receive a milestone payment of $30 million from Mylan and an additional $70 million in payments contingent upon reaching further clinical and regulatory achievements. Mylan would commercialize the product in the United States, Europe, and other markets worldwide.

“We are pleased with Mylan’s decision to opt in to the biosimilar to BOTOX development program, as it reflects our mutual confidence in the path forward,” said Mark Foley, president and CEO of Revance Therapeutics. “Assuming regulatory approval, it would allow us to financially participate in the short-acting neuromodulator market, while focusing our commercial efforts on creating the new, long-acting neuromodulator category.”

The decision to move forward with a regulatory application was delayed when Revance last year gave Mylan more time, until April 2020, to commit to developing and commercializing the proposed biosimilar.

Although onabotulinumtoxinA has a cosmetic use market, it also is approved for neurological-related incontinence, prophylaxis of headache for migraines, upper limb spasticity, cervical dystonia, and strabismus.

Although it is not fully clear how Revance’s daxibotulinumtoxinA and onabotulinumtoxinA products would be commercialized to avoid overlapping sales activity, Revance said it continues with clinical trials for injectable daxibotulinumtoxinA in therapeutic indications, including cervical dystonia (phase 3), upper limb spasticity (phase 2), and plantar fasciitis (phase 2).

The company said topline results for this agent are expected in the second half of 2020 for the cervical dystonia and plantar faciitis studies.