Eye on Pharma: Mylan Could Develop the First True Botox Biosimilar

Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.

Mylan said that the FDA’s feedback leads it to believe that the biosimilar approval pathway is viable for this product, and that Mylan could be the first developer to commercialize a biosimilar onabotulinumtoxinA.

The originator onabotulinumtoxinA, a neuromuscular blocking agent, is approved to treat conditions including incontinence due to neurological conditions, prophylaxis of headache in patients with migraine, upper limb spasticity, cervical dystonia, and strabismus, among other indications, such as its cosmetic uses.

Mylan’s development partner for the candidate, Revance, said that successful completion of a biosimilar program could result in FDA approval for all 11 FDA-approved indications for the reference product, and Revance’s president and chief executive officer said in a recent earnings call that “we know what needs to be done, and the FDA has set the right level of expectations” for biosimilar approval.

Allergan and Medytox, makers of the brand-name Botox, face a recent competitor, the recently FDA-approved prabotulinumtoxinA-xvfs, marketed as Jeuveau. Despite being a purified botulinum toxin type A, like the innovator Botox, the newly authorized product was submitted to the FDA under a new Biologics License Application, and was not treated as a biosimilar of the innovator Botox. Its developer, Evolus, in partnership with drug maker Daewoong, sought only indications for the product’s aesthetic use, and the product is not approved for medical indications.

Allergan and Medytox are hoping to block Jeuveau’s sales in the United States; the companies filed a complaint with the US International Trade Commission in which they asked for an investigation into Evolus’ manufacturing of botulinum toxin products. While details of the complaint are confidential, Bloomberg reported that Allergan and Medytox have alleged that the rival product was developed using manufacturing secrets stolen by an Evolus employee.

Allergan and Medytox seek an immediate investigation into whether the product was developed, made, or imported using stolen secrets, and ask for Evolus to be prohibited from selling the drug in the United States.