Tagged as: Evolus

ALJ Recommends Exclusion in Botox Trade Secret Case

We previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus.  In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  A one-page public notice provides…

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Biosimilar and Biologic Development Updates

On Wednesday, Celltrion announced its completion of its Phase 3 clinical trial for Remsima SC, a subcutaneous version of its biosimilar Remsima® (infliximab).  According to Celltrion, “[t]he subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to…

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Evolus Announces Progress with Botox Follow-on Biologic

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…

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