Resources

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

Position Statements

September 24, 2015

The Need for “Meaningful” Suffixes for Biosimilar and Biologic Names

On August 27, the U.S. Food and Drug Administration (FDA) released draft guidance calling for biological products to bear non-proprietary names that include a distinguishable suffix designated by the FDA. The Biologics Prescribers Collaborative (BPC) applauds the agency for recognizing that “there is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable.” Read More ›

August 27, 2015

BPC Statement on FDA Draft Guidance entitled “Nonproprietary Naming of Biological Products”

Biosimilars are not generics and the BPC applauds the FDA for recognizing that each biosimilar needs a distinguishable name in its draft guidance issued today. The FDA’s draft guidance on nonproprietary naming of biological products proposes distinguishable names, calling for biological products to bear a nonproprietary name that includes an FDA-designated suffix. This proposal reflects the agency’s thinking that “there is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable.” Read More ›

March 9, 2015

HOPA Statement on First Biosimilar Product Approved in the United States

(March 2015): The Hematology/Oncology Pharmacy Association (HOPA) is encouraged by the Food and Drug Administration’s (FDA) approval of the first biosimilar product, Zarxio (filgrastim-sndz), in the United States, but strongly urges the FDA to develop a naming policy for approved biosimilars. HOPA believes that naming is important to avoid prescribing and dispensing errors and that biosimilars must be able to be easily tracked to monitor safety and quality. Read More ›

March 6, 2015

Biologics Prescribers Collaborative (BPC) Statement on FDA Approval of Filgrastim Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)’s decision today to approve the first biosimilar in the United States, Sandoz’s biosimilar to Amgen’s Neupogen™ (filgrastim). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies. Read More ›

November 2, 2010

Testimony of Immune Deficiency Foundation (IDF) at FDA Hearing on Biosimilar Pathway

On November 2, 2010, Marcia Boyle, president and founder of the Immune Deficiency Foundation (IDF), testified on the need to ensure the safe use of biosimilars at an FDA public hearing entitled, “Approval Pathway for Biosimilar Interchangeable Biological Products.” Read More ›