Please see the resources below to learn more about the issues surrounding the use of biosimilars.
January 16, 2017
The U.S. Food and Drug Administration (FDA) on Thursday released its final guidance for industry on the "Nonproprietary Naming of Biological Products." The move generated positive reaction from physician groups and other health professionals. Read More ›
June 13, 2016
On Monday, June 13, 2016, six groups representing a broad spectrum of biologic prescribers – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, and Endocrine Society – sent a letter to Health, Education, Labor and Pensions (HELP) Committee Chairman Senator Lamar Alexander (R-TN) and Ranking Member Senator Patty Murray (D-WA), commending the bipartisan sponsorship of Section 11 of S. 2700, a provision of the 21st Century Cures Act that assures full U.S. Food and Drug Administration (FDA) authority over the identity (name) and quality standards for biologic products, including biosimilars. Read More ›
March 6, 2015
March 6, 2015 - The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Read More ›