Last week, Evolus, Inc. announced updates to the regulatory progress of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox (onabotulinumtoxinA injection) product.  Evolus reported that FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd., Evolus’s contract manufacturer for DWP-450.  According to Evolus, the EIR confirmed the favorable completion of FDA’s pre-approval inspection of Daewoong’s manufacturing facility in South Korea.

Evolus also announced that FDA has issued a Complete Response Letter (“CRL”) to Evolus related to its BLA for DWP-450.  Evolus stated that the deficiencies cited by FDA in the CRL were isolated to items related to CMC processes and no deficiencies were related to clinical or non-clinical matters.  David Moatazedi, President and Chief Executive Officer of Evolus, commented that Evolus “expect[s] to respond [to the CRL] comprehensively within 90 days,” and that Evolus “remain[s] committed to bringing DWP-450 to market by spring 2019.”

As we have previously reported, Mylan and Revance are jointly working on a Botox biosimilar product.