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 visit hospitals for the administration there of.” Celltrion states that it expects to submit its Marketing Authorization Application to the European Medicines Agency (EMA) in the second half of this year.

Also on Wednesday, Evolus announced that the FDA has accepted Evolus’ resubmission of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection) product.  According to Evolus, the FDA considered the resubmission a Class 2 response and has assigned it a February 2, 2019 action date per the Prescription Drug User Fee Act (PDUFA).

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