Mylan Set To Develop Biosimilar Botox In Deal With Revance
Mylan's revenue was down due to issues in the North American market, but the company is looking forward to development of new products to balance out losses in the future, including a newly announced Botox biosimilar.
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CEO Heather Bresch talked to Scrip about how she will navigate the company through what has become a rough period for the US generic drug market and validation on complex generics and biosimilars.
Phase III data show statistically significant wrinkle-reducing results for up to six months across two trials for Revance's neuromodulator RT002. With a safety study ongoing, the Botox competitor isn't likely to hit the market until 2020, but it's yet another piece of bad news for Allergan.
FDA issued a complete response letter for Mylan's application for a biosimilar version of Amgen's Neulasta. However, Mylan said the CRL does not change its US launch expectations, targeted for late 2018 or early 2019.