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.