Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

According to the Amgen—Allergan partnership, the list price of both products will be 15% lower than their respective reference products.

Mvasi was made available at a list price of $677.40 per 100 mg, and $2709.60 per 400-mg single-dose vial. Kanjinti was made available at a list price of $3697.26 per 420-mg multi-dose vial. These list prices put Mvasi 12% below Avastin’s average selling price (ASP), and Kanjinti 13% below Herceptin’s ASP.

The list prices do not take into account discounts and rebates, and the biosimilar makers say that they expect out-of-pocket costs for patients to vary depending on insurance status and eligibility for patient assistance programs.

"Several years ago, Amgen made the strategic decision to invest in building a global biosimilars business, leveraging our nearly [4] decades of experience in developing and manufacturing best-in-class biologics," Murdo Gordon, executive vice president of global commercial operations at Amgen, said in a statement announcing the launches. "Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the [United States], which will provide for immediate savings for Medicare patients and commercial payers. We have several more biosimilars advancing through our pipeline, even as we continue to drive innovation through novel therapies for cancer and other serious diseases,” Gordon added.

Mvasi was the first bevacizumab biosimilar—and the first anticancer biosimilar—to be authorized in the United States, earning the FDA’s approval in September 2017 after receiving a unanimous vote in favor of its approval from the FDA’s Oncologic Drugs Advisory Committee.

Kanjinti joined the ranks of FDA-approved biosimilars more recently, earning its approval in June 2019 after the drug makers first received a Complete Response Letter for the product in 2018 and subsequently worked with the agency to address its concerns. Kanjinti was the fifth trastuzumab biosimilar to gain FDA approval, but it is the first to launch in the United States.

Notably, this week’s launch of Kanjinti comes on the heels of news that Herceptin-maker Genentech had filed a motion for a temporary restraining order, and a motion for a preliminary injunction against Amgen, in a Biologics Price Competition and Innovation Act litigation related to patents covering Herceptin. According to Big Molecule Watch, a judge denied Genentech's motions.

Launch of these products brings the total number of biosimilars in the US marketplace to 9, following the previous market availability of the supportive care and inflammatory disease biosimilars Zarxio, Inflectra, Renflexis, Fulphila, Retacrit, Nivestym, and Udenyca.