Mylan partners to make Botox biosimilar

Mylan has revealed plans to develop and commercialise a proposed biosimilar to Botox (onabotulinumtoxinA).

Under a global collaboration and licence agreement with Revance Therapeutics, the companies will work together to gain regulatory approval and commercialise the biosimilar in the US, Europe and other markets.

Mylan will pay Revance, a biotechnology company focused on developing neuromodulators, $25 million up front.

For Mylan, the biosimilar further solidifies its long-term commitment to the development and commercialisation of biosimilars and complex products.

In a press release issued on Wednesday, February 28, Rajiv Malik, president of Mylan, said that the deal was a significant opportunity for Mylan as it adds another “difficult-to-manufacture product” to its pipeline.

“Bringing an affordable biosimilar version of Botox to commercialisation will offer patients a safe alternative to this popular and highly effective treatment.”

According to Dan Browne, president and CEO of Revance, global neuromodulator sales for all companies are currently estimated at $4 billion and forecasted to exceed $7 billion by 2024.

Revance is also focusing on the development and launch of its long-acting neuromodulator, RT002, for the treatment of cervical dystonia (where neck muscles contracting involuntarily), plantar fasciitis (a thickening of the plantar fascia in the foot) and frown lines.

Browne added that the partnership allows Revance to remain focused on developing RT002 while also “benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to Botox”.

Allergan, which sells Botox, announced that it was set to acquire Australia-based  Elastagen, a clinical-stage company focused on developing medical device products based on recombinant tropoelastin, for $95 million in February.

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