They’re Here—Cancer Biosimilars Enter U.S. Market

The biosimilar market is heating up. The U.S. Food and Drug Administration (FDA) has approved 23 biosimiliars to date, and they are increasingly being made available to U.S. consumers. In July, Amgen and Allergan launched the first two anticancer biosimilars in the U.S. market. According to their manufacturers, these biologics alternatives—Mvasi®, a bevacizumab biosimilar referencing Avastin®, and Kanjinti®, a trastuzumab biosimilar referencing Herceptin®—will be offered with list prices an estimated 15 percent lower than that of their respective reference products. While Kanjinti® is approved for the treatment of certain breast and metastatic stomach or gastroesophageal junction cancers, Mvasi® has been approved for the treatment of certain colorectal, lung, brain, kidney, and cervical cancers.

In hopes of making the biologics market more competitive, Congress paved the way for the approval of biosimilars in 2010 with the passage of the Biologics Price Competition and Innovation Act, which created an abbreviated regulatory process for biosimilars. Proponents for biosimilars say they will produce long-term savings that can be passed on to providers, practices, health systems, and patients, who are increasingly struggling with the high price tags of biologics.

Those price tags are adding up. Biologics constitute a large and rapidly growing market. According to the National Cancer Institute, in 2005, biological products accounted for more than 39 percent of the $9.5 billion Medicare spent on prescription drugs. By 2014, Medicare drug-spending had risen to $18.5 billion, of which 62 percent was spent on biologics.

The introduction of biosimilars into the market is expected to decrease such spending. In a 2017 RAND study, researchers estimated that the use of biosimilars would lead to a reduction of $54 billion in direct spending on biologic drugs from 2017 to 2026—or about 3 percent of the total estimated spending on biologics during the same period.

The increased use of biologics reflects the fruits of a rapidly evolving understanding of the biology of cancer. Keeping up with such developments requires knowledge of new drug approvals, new indications for previously approved anti-cancer agents, and increasingly complex treatment regimens. Oncology pharmacists in particular must stay abreast of these changes within an ever-evolving regulatory and reimbursement environment. ACCC's Oncology Pharmacy Network (OPEN) was created to help oncology pharmacists navigate the accelerating course of change in the management of the oncology pharmacy by offering educational opportunities, comprehensive resources, and peer-to-peer networking that can give them the knowledge they need to succeed. For more read an OPEN Insight brief on integration of biosimilars within a community, academic, or health system setting.

The upcoming ACCC 36th National Oncology Conference in Orlando, Florida, from Oct. 30 to Nov. 1, will feature a full-day OPEN Pre-Conference on Wednesday, Oct. 30, to explore solutions to the most critical challenges facing oncology pharmacists and allied staff—including the issues related to the integration of biosimilars into practice. Learn More.
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The ACCC 36th National Oncology Conference early bird registration rate ends September 6, 2019. Register Now.