Tagged as: Botox

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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Update on biosimilar launches and development

Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea.  Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…

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