FDA Approval of Biosimilars Picking Up Pace

Monday December 10, 2018

On Friday, December 14, the U.S. Food and Drug Administration (FDA) announced its sixteenth biosimilar approval for biosimilar trastuzumab, a drug used in chemotherapy. This approval builds on the FDA’s November 28 announcement that it had approved a biosimilar rituximab. These recent approvals reemphasize the agency’s commitment to expanding patient access to biosimilars. Introduction of these drugs will lead to increased access to lower-cost treatments for cancer patients. As is the case with all biosimilars available to American patients, FDA approval ensures that these medicines are both safe and effective.

Through November and the first half of December, the FDA has approved three biosimilars. FDA Commissioner Scott Gottlieb, M.D., recently provided a statement expanding on the agency’s focus on biosimilar approvals:

“As part of the FDA’s Biosimilars Action Plan we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines…The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval.”

The Biosimilars Council is supportive of the FDA’s Biosimilars Action Plan and values the agency’s partnership in improving the lives of American patients. We hope this accelerated rate of biosimilar approval will be sustained or increased as additional biosimilar drugs progress through the approval process.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.

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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.