Resources

Please see the resources below to learn more about the issues surrounding the use of biosimilars. 

FDA News

January 16, 2017

FDA Releases Final Guidance for ‘Nonproprietary Naming of Biological Products’

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

Physician Groups Support Bill Providing Authority to FDA on Biologics

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

FDA News Release: FDA approves first biosimilar product Zarxio

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 ›

September 1, 2014

FDA Purple Book Release

In September 2014, FDA released its “Purple Book,” a list of the biological products, including biosimilars and interchangeable biological products—licensed by FDA. Read More ›