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Revance and Mylan move forward with Botox biosimilar Posted 10/07/2020

US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).

Botulinum toxin, or Botox, which is the market-leading neuromodulator, according to Revance, is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis [2]. Infection with the bacterium causes the disease botulism. The toxin is also used commercially for medical and cosmetic purposes.

Botox has become famous for its use in cosmetic clinics. Isolated from a group of pathogenic bacteria, in extremely low doses the toxin can reduce facial wrinkles. It also has therapeutic applications in reducing spasms in muscle disorders and has recently shown benefits for migraine headaches.

Revance first teamed up with generics giant Mylan in February 2018 to make a biosimilar of Botox (onabotulinumtoxinA) [1]. However, the company later announced an amendment to its agreement, extending the target date to 30 April 2020 for Mylan to decide whether to continue development of the product [2].

The decision to move ahead came after the pair obtained feedback from the US Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019, which indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development programme.

Mylan’s decision to move forward means a payment of US$30 million is now payable to Revance. Furthermore, the collaboration and license agreement also provide for an additional US$70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets.

Related article
FDA rejects botulinum toxin biosimilar from Evolus

References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Revance team up for botox biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Revance-team-up-for-botox-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 10]. Available from: www.gabionline.net/Biosimilars/News/Revance-Therapeutics-focus-on-its-own-Botox-biosimilar-as-work-with-Mylan-is-stalled

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Source: Revance

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