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Merck, Samsung join newly crowded market for Herceptin biosimilars

Merck & Co. on Wednesday announced the U.S. launch of Ontruzant, its biosimilar version of the breast cancer therapy Herceptin.
Measured by list price, the copycat medicine will cost 15% less than the original blockbuster developed by Roche’s Genentech, in line with the discounts offered by the four other Herceptin biosimilars already on market.
Ontruzant, developed in partnership with Samsung Bioepis, won Food and Drug Administration approval in January 2019. Samsung is responsible for development and manufacturing, while Merck is in charge of commercialization.

Merck is bringing Ontruzant to market at a challenging time. The need for social distancing amid the COVID-19 epidemic means that healthcare facilities are limiting visits from field representatives and fewer contracts likely will be signed, analysts at Bernstein wrote in a recent note to investors. That could particularly affect new launches like Ontruzant.

The cancer biosimilar also follows a raft of other Herceptin copycats onto market. Amgen, Mylan, Pfizer and Teva have already introduced versions of the medicine, shaping the most robust biosimilar market by number of entrants. Amgen so far leads, having won about 17% market share, according to Bernstein.

Even with competition, the discounts being offered are relatively low, ranging from 10% to 22% when compared to branded Herceptin’s wholesale acquisition cost. By contrast, biosimilar versions of Amgen’s blockbuster Neulasta cost 33% less than the original. Neulasta is used to help boost white blood cells after cancer treatment.

Herceptin, approved by the FDA in 1998, represented a revolutionary step in breast cancer treatment. It works by inactivating a protein produced by the HER2 gene present in some breast cancer patients. That, in turn, allows a targeted attack on the tumor instead of a full-out blitz on the body that comes with traditional chemotherapy.

Ontruzant will cost about $1,325 for a 150 mg single-dose vial and $3,709 for a 420 mg multiple-dose vial, Merck said.

Merck said it still intends to spin off products from its Legacy Brands and Biosimilars business, and Ontruzant will become part of the new company. Until then, Merck said it will “fully support the commercialization of the product. The drugmaker plans to complete the spinoff in the first half of 2021.