Botox, the most sought after aesthetic treatment and a multi-billion grossing product from Allergan’s niche portfolio was approved as a biologic back in 1991 and has since remained an undisputed player in the category, extending its neuro-modulating applications into therapeutic areas as well. A major challenge with respect to developing a biosimilar to Botox was its complex and secretive manufacturing process and the fact that it contains one of the most deadly toxins in the world- botulinum toxin, a classified bioterrorism hazard.
Revance and Mylan entered into a collaboration in 2018 to develop a Botox biosimilar and after a brief halt, they are now proceeding to file a 351(k) application to the US FDA for their proposed biosimilar onabotulinumtoxinA. Revance is the developer of the biosimilar and Mylan is responsible for its commercialization in the United States, Europe and other markets. Mylan and Revance originally signed a collaboration and license agreement in February 2018 but amended it in September 2019 to provide Mylan an extended decision period to move forward in exchange for an incremental one-time payment of $5 million to Revance. With the inclusion of this additional $5 million, Revance will receive a milestone payment of $30 million from Mylan and an additional $70 million in payments on meeting clinical and regulatory milestones.
The biosimilar program being developed through this collaboration would compete in the existing short-acting neuromodulator market. Additionally, Revance has also completed a Phase 3 study for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, the unpartnered lead program for Revance.
Allergan reaps revenue north of $2 billion annually from the aesthetic and therapeutic applications of Botox. While its biosimilar may provide a cheaper alternative to Botox, its aesthetic application holds a major share of its sales and the customers it serves are the ones who are willing to pay out of their pockets for a high-end aesthetic intervention. A single application of Botox for wrinkle treatment lasts for about 3-4 months in average, thus, it enjoys a pool of repeat customers; and whether the biosimilar is able to counter the brand loyalty and trust established by Botox will determine its success in that segment. In the therapeutic category, a biosimilar would offer a greater benefit to patients by providing a cheaper alternative and is likely to steal some market share from Allergan. It will be interesting to see how the market shapes up once the biosimilar makes its market entry.