Viatris Confirms Delay On ‘First And Only’ Botox Biosimilar
Problems For Partner Revance’s Lead Pipeline Candidate Has ‘Direct Impact’
Viatris remains hopeful of obtaining FDA approval for its proposed biosimilar to Botox in partnership with Revance Therapeutics in 2026, after the latter’s manufacturing problems for another drug candidate stymied development of the rival to the world-renowned cosmetic brand.
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Facing down a key patent infringement trial beginning on 19 May, Viatris is continuing to eye an opportunity to launch its Breyna generic version of AstraZeneca’s Symbicort before patent expiry in 2023.
Biocon Biologics will pay up to $3.3bn to acquire the global biosimilars business of Viatris, in a long-rumored deal that will create a vertically-integrated biosimilars giant with annual sales approaching $1bn.
Viatris provided several key updates for its biosimilar pipeline during the company’s Q3 earnings call, including for its biosimilar Eylea and Botox candidates, as well as disclosing another key early-stage asset.