Merck, Samsung Bioepis roll out Herceptin biosimilar

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Merck, Samsung Bioepis roll out Herceptin biosimilar

By Sandra Levy - 04/24/2020

Ontruzant (trastuzumab-dttb), a biosimilar of Roche’s Herceptin, is now available for the treatment of certain types of breast and gastric cancers.  

Merck is launching Ontruznat in the United States as part of a development and commercialization agreement with Samsung Bioepis.

Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials, and regulatory registration. Merck will be responsible for all commercialization activities for products approved in its partnered territories, including the United States.

Ontruzant is available in 50 mg single-dose vials and 420 mg multiple-dose vials. The Food and Drug Administration approved Ontruzant in January 2019.

Ontruzant will be introduced at a list price, or wholesaler acquisition cost, of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin.

Wholesaler acquisition costs do not include discounts to payers, providers, distributors and other purchasing organizations.

On Feb. 5, 2020, Merck announced that it intends to spin off products from its women’s health, trusted legacy brands and biosimilars businesses, including Ontruzant, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of Ontruzant until the spin-off, which is intended to take place in the first half of 2021, at which time Ontruzant will become a product of the new company.

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