Mylan plots to bring Botox biosimilar to market

1 March 2018
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Mylan (Nasdaq: MYL) and Revance Therapeutics (Nasdaq: RVNC) today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to Botox (onabotulinumtoxinA).

Allergan’s Botox is the market-leading neuromodulator approved for the treatment of multiple indications and usage in the USA with additional approvals globally. Although the product is off patent, no biosimilars have emerged so far. California biotech Evolus has a Botox biosimilar under review with the FDA – but a May decision date looks uncertain because of issues with a manufacturing plant in South Korea.

Assuming Mylan succeeds in getting a biosimilar on the market, it will also compete with French drugmaker Ipsen’s Dysport (abobotulinumtoxinA), which is the main competitor to Allergan’s brand.

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