This morning, Merck issued a press statement to announce that it had joined the trastuzumab biosimilar fray, with the launch of Ontruzant®, which was developed by its partner Samsung Bioepis.
This marks the fifth biosimilar to Herceptin® that has become available for prescription. However, the retail price or wholesale acquisition cost (WAC) price is approximately $1,325 for the 150-mg single-dose vial and $3,709 for the 420-mg multiple-dose vial or only a 15% discount to the reference product. In order to obtain business in such a competitive drug class, additional discounts and rebates will no doubt be necessary.
Ontruzant, which was approved by the Food and Drug Administration in January 2019, received licensing approval by the European Medicines Agency in 2017 (and was launched in the EU some time ago). Trastuzumab is used to treat breast cancer tumors overexpressing HER2+ receptors.
This announcement heralds what may be the final launch of a Herceptin biosimilar in the United States. No other biosimilar manufacturers have publicly announced plans for US filings for new trastuzumab biosimilars.
As previously reported, Merck will spin off its biosimilar business (in addition to legacy brands and women’s health products) into a new company in 2021. Until this time, the parent company will continue to commercialize biosimilars under the Merck and Samsung Bioepis partnership agreement. This currently includes the launched agents Ontruzant and Renflexis®.
In other biosimilar news…America’s Health Insurance Plans (AHIP) issued a statement that applauded the Food and Drug Administration’s and Federal Trade Commission’s actions to combat misinformation on biosimilars. At the same time, this payer organization urged the agencies to do more, including eliminating pay-for-delay deals to hold off biosimilar launches, hindering the use of Citizen’s Petitions as a delaying tactic, and transforming the Purple Book into a more accessible and useful reference. The statement by AHIP was in response to a joint workshop by FDA and FTC that was held in March, but was considered by many to be too limited in scope.