Biosimilar pharmaceutical products are biologic drugs products that are approved by the U.S. Food and Drug Administration and the European Medicine Agency based on proven and highly similarity to an approved biologic product, known as a reference drug, without clinically meaningful differences in terms of safety and effectiveness from the reference product.

Only minor differences in clinically inactive components are permitted of a drug is to be accepted as a biosimilar product.

Amgen and Allergan have confirmed that the first biosimilar versions of bevacizumab (Avastin®; Genentech/Roche) and trastuzumab (Herceptin®; Genentech/Roche) have been approved for distribution in the United States.

The products include bevacizumab-awwb (Mvasi™), a biosimilar to bevacizumab, and trastuzumab-anns (Kanjinti™), a biosimilar to trastuzumab.

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

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Trastuzumab-anns is FDA approved for all approved indications of trastuzumab: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Important step
“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.

“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 Wholesale Acquisition Cost (WAC or “list price”) of both bevacizumab-awwb and trastuzumab-anns will be 15% lower than their reference products. bevacizumab-awwb is being made available at a WAC of $677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less than the WAC for bevacizumab.

Bevacizumab-awwb is being made available at a WAC of $3,697.26 per 420 mg multi-dose vial, 15% below the WAC of Herceptin.

At launch, bevacizumab-awwb is priced 12% below the current bevacizumab Average Selling Price (ASP) and trastuzumab-anns is priced 13% below the current Herceptin ASP. Both products will be available from both wholesalers and specialty distributors.

“Several years ago, Amgen made the strategic decision to invest in building a global biosimilars business, leveraging our nearly four decades of experience in developing and manufacturing best-in-class biologics,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen.

More biosimilars drugs in the pipeline
“Following several recent launches in Europe, we are excited to be launching our first two biosimilars in the U.S., 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.”

The WAC price measure does not account for discounts and rebates and may be significantly higher than out-of-pocket cost for patients, which can vary depending on several factors. Medicare and commercial insurance, for example, will generally pay for bevacizumab-awwb and trastuzumab-anns based on ASP rather than WAC.

Out-of-pocket cost may also depend on and be reduced by additional factors, including eligibility for patient assistance.

Actual costs to patients and providers for bevacizumab-awwb and trastuzumab-anns are anticipated to be lower than WAC as WAC does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance. bevacizumab-awwb and trastuzumab-anns will be available from both wholesalers and specialty distributors.

“As the first products from our collaboration with Amgen to be launched in the U.S., bevacizumab-awwb and trastuzumab-anns reinforce our ongoing dedication to providing patients with additional treatment options,” said David Nicholson, chief research and development officer at Allergan.

“We are excited about the progress we’ve made through this partnership and look forward to continued milestones together with our remaining biosimilar products,” Nicholson concluded.

High quality drugs
Amgen and Allergan are committed to developing high-quality biosimilars supported by robust analytical and clinical packages. Bevacizumab-awwb and trastuzumab-anns were proven to be highly similar to, and to have no clinically meaningful differences in terms of safety and effectiveness from bevacizumab and Herceptin, respectively, based on a totality of evidence, which included comparative analytical, clinical safety and efficacy data.

At the time of FDA approval, trastuzumab-anns was the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, in which a portion of patients who began the study on Herceptin made a single transition to trastuzumab-anns. This portion of the study demonstrated similar safety and immunogenicity in patients on trastuzumab-anns who were previously treated with trastuzumab.

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S.


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