BIOSIMILARS

Many types of biological products are used therapeutically and for supportive care for patients with cancer. Biologics are large, complex molecules that are produced by biotechnology in a living system (for example, a microorganism, plant, or animal cell). The U.S. Food and Drug Administration (FDA) regulates and approves biological products, which include therapeutic proteins and monoclonal antibodies, as well as vaccines.

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an already-approved FDA biological product (referred to as the reference product). For more information, access the FDA Biological Product Definitions.

In Europe, biosimilars have been in use for more than a decade; since 2006, 30 biosimilars have been approved and have been shown to reduce costs and increase patient access to these products.

In the U.S., Congress enacted legislation to create an abbreviated regulatory process for biosimilars, The Biologics Price Competition and Innovation Act of 2009. With the introduction of biosimilars to the U.S. market, the hope is to produce long-terms savings that can be passed on to the healthcare system and patients.

In 2015, the first biosimilar approved in the U.S. was filgrastim-sndz (Zarxio), a biosimilar to filgrastim (Neupogen), a supportive care drug used to prevent infection during chemotherapy.

In July 2019, the first two therapeutic anticancer biosimilars launched in the U.S. market in July 2019. As of December 2019, the FDA has approved 26 biosimilars (not all in oncology).

Although biosimilars offer the potential cost savings for the U.S. healthcare system, integrating biosimilars into practice requires a thorough understanding of biosimilars by the multidisciplinary cancer care teams and easy access to vetted centralized information on effective steps for introducing these drugs into the oncology workflow.