Tagged as: Botox

Medytox Files ITC Complaint Against Hugel to Block Import of Botox Follow-On

On March 30, 2022, Medytox filed a complaint with the ITC requesting that the ITC block imports of Hugel’s follow-on biologic Letybo® (LetibotulinumtoxinA) product.  The complaint alleges that Hugel expects to obtain approval and launch its product in the U.S. in 2022.  The complaint alleges that “Hugel misappropriated Medytox’s trade…

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Commission Issues Exclusion Order in Botox Trade Secret Case

In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  Since that time, the parties have submitted lengthy Petitions for Review and answered questions raised by the Commissioners.  Now, the Commission has ruled….

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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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Allergan Files ITC Complaint Against Evolus to Block Imports of Newly Approved Botox Follow-On

On January 30, 2019, Allergan and its partner Medytox filed a complaint with the ITC to block imports of Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection) product, DWP-450, manufactured by Daewoong Pharmaceuticals.  The complaint alleges that Daewoong misappropriated trade secrets of Medytox. Evolus filed a BLA for DWP-450 and it was accepted…

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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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Update on biosimilar launches and development

gloved hand withdraws drug solution with syringe

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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