✦ Ontruzant (trastuzumab-dttb) launched on April 15. Merck & Co., Inc. will commercialize the Herceptin (trastuzumab) biosimilar in the U.S. per a deal with Samsung Bioepis Co., Ltd. Ontruzant is available in 150 mg single-dose vials and 420 mg multiple-dose vials. The wholesale acquisition cost for the 150 mg vial is $1,325, and the WAC for the 420 mg vial is $3,709. Both are discounts of 15% off Herceptin’s list price. Merck will market and distribute it in the U.S. until the drugmaker spins off Ontruzant and other products to a new yet-to-be named, independent, publicly traded company, which is expected to occur in the first half of 2021. Visit www.merckconnect.com/ontruzant.
✦ Teva Pharmaceuticals USA, Inc. and its parent company Teva Pharmaceutical Industries Ltd. filed a lawsuit (No. 1:20-cv-00808) against the FDA and HHS over the decision not to transition Copaxone (glatiramer acetate) from the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act (RSP 3/20, p. 4). On March 23, 100 products made the transition as mandated by the Biologics Price Competition and Innovation Act. Teva is claiming that the FDA’s decision is “arbitrary, capricious, and contrary to law, and it thus should be set aside under the Administrative Procedure Act.” View the lawsuit at https://bit.ly/3b8Porb.