First Oncology Biosimilars Launched in United States

The first oncology therapeutic biosimilars are now available in the United States.

Amgen and Allergan recently announced the launch of Allergan’s bevacizumab-awwb (Mvasi), a biosimilar to Avastin, and trastuzumab-anns (Kanjinti), a biosimilar to Herceptin, according to a press release.

Indicated for the treatment of 5 different types of cancer, bevacizumab-awwb was the first oncology biosimilar to be approved by the FDA in 2017. Bevacizumab is approved for the treatment of adult patients with certain types of colorectal, lung, brain, kidney, and cervical cancers.

Trastuzumab-anns, the fifth biosimilar referencing Herceptin, is FDA-approved for all indications of the branded product, including the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

According to Amgen and Allergan, the wholesale acquisition cost of both biosimilars will be 15% lower than their reference products. Bevacizumab-awwb will be available at a list price of $677.40 per 100 mg and $2709.60 per 400 mg single-dose vial and trastuzumab-anns will be listed at $3697.26 per 420 mg multi-dose vial. These list prices place bevacizumab-awwb at 12% below the current Avastin average selling price (ASP) and trastuzumab-anns at 13% below the current Herceptin ASP, the companies said.

However, these price measures do not account for discounts and rebates, so out-of-pocket costs may vary for patients depending on several factors, such as insurance and eligibility for patient assistance, according to Amgen.

“Several years ago, Amgen made the strategic decision to invest in building a global biosimilar 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. “Following several recent launches in Europe, we are excited to be launching our first 2 biosimilars in the US, 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.”

Following the launch of these products, there are now 9 total biosimilar products available in the US market: Zarxio, Inflectra, Renflexis, Fulphila, Retacrit, Nivestym, and Udencya.

Reference

Amgen and Allergan’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns) now available in the United States [news release]. Amgen. https://bit.ly/2Z9YFdz. Accessed July 19, 2019.