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First Anticancer Biosimilar Products Reach US Market

July 23, 2019

Biosimilars to bevacizumab and trastuzumab are the first biosimilar products to have reached the US market.

In a recent press release from Amgen and Allergan (July 18, 2019), bevacizumab-awwb (Mvasi) and trastuzumab-anns (Kanjinti) were announced as the first products to reach the market. The list price for each drug will be 12% to 15% less than the wholesale acquisition cost for the branded products (bevacizumab [Avastin] and trastuzumab [Herceptin], respectively).

Bevacizumab-awwb was the first oncologic biosimilar approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of five types of cancer: in combination with chemotherapy for metastatic colorectal cancer; in combination with chemotherapy for non-squamous non-small cell lung cancer; recurrent glioblastoma; in combination with interferon-alfa for metastatic renal cell carcinoma; and in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer.

Trastuzumab-anns was approved by the FDA for the same indications as trastuzumab: treatment of HER2-overexpressing adjuvant and metastatic breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers," said Paula Schneider, chief executive officer, Susan G Komen Breast Cancer Foundation, in the press release. "As patient advocates, we are working to ensure that patients are educated about biosimilars and understand that these FDA-approved treatments are just as effective as the original biologic drugs."

The biosimilar to bevacizumab is being made available at a wholesale acquisition cost of $677.40 per 100 mg and $2709.60 per 400 mg single-dose vial. Trastuzumab-anns is being made available at a wholesale acquisition cost of $3697.26 per 420 mg multi-dose vial. At launch, bevacizumab-awwb is priced 12% below the current bevacizumab average selling price and trastuzumab-anns is priced 13% below the current trastuzumab average selling price, according to Amgen and Allergan.

"As the first products from our collaboration with Amgen to be launched in the US, bevacizumab-awwb and trastuzumab-anns reinforce our ongoing dedication to providing patients with additional treatment options," said David Nicholson, chief research and development officer, Allergan, in the press release. "We are excited about the progress we have made through this partnership and look forward to continued milestones together with our remaining biosimilar products."

Actual costs to patients and providers for these biosimilars will likely be lower than their wholesale acquisition costs because this measure does not reflect discounts or rebates. Out-of-pocket costs to patients will vary according to insurance status and eligibility for patient assistance.—Zachary Bessette

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