Following the announcement that the FDA have accepted Evolus’ BLA resubmission for their Botox biosimilar,
Rahael Maladwala, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on what this could mean for pharma company:
“Evolus had their previous BLA submission rejected by the FDA in May 2018 due to concerns over Chemistry, Manufacturing and Controls (CMC) protocol for the Botox biosimilar, DWP-450. However, the pharma company have addressed these concerns and now the Botox copy is back on track for a spring 2019 launch in the US.
“Botox is one of the most evergreen drugs on the market; originally released in 1989, it has maintained patent protection by being repurposed for new indications and through a series of label expansions. Combining this with the difficulty of producing an effective biosimilar has meant that Botox has maintained market share with little competition.
‘‘Global sales of Botox have been trending upwards over the last ten years and according to GlobalData reached just under $3.2bn in 2017, and Evolus are now looking to steal some of that market share.
“However, Evolus are not the only company looking to release a Botox biosimilar with Hugel and Revance/Mylan also looking to take a portion of the neurotoxin market. This means that market positioning will play an important role in determining the share each biosimilar will be able to gain.
“After addressing the CMC concerns raised by the FDA, Evolus are now well positioned to take advantage of the lucrative neurotoxin market with a predicted spring 2019 launch.”