Resources

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

Latest Resources

October 27, 2015

Physician Groups Applaud FDA for Distinguishable Naming; But Argue Against ‘Random’ Suffix

WASHINGTON, October 27, 2015 – On Tuesday, October 27, 2015, eight groups representing a broad spectrum of biologics prescribers – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Association of Black Cardiologists, Inc., Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, Endocrine Society, and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – applauded the U.S. Food and Drug Administration (FDA) for supporting distinguishable names for all biologic products via a unique suffix, but said the suffix should be an easy to remember reference to the manufacturer’s name. FDA currently wants a suffix of random letters that is “devoid of meaning.”  Read More ›

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On August 27, the U.S. Food and Drug Administration (FDA) released draft guidance calling for biological products to bear non-proprietary names that include a distinguishable suffix designated by the FDA.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 ›

September 2, 2015

Physician Groups Urge CMS to Adopt Unique Billing Codes (J-codes) for Each Biosimilar

On September 1st, BPC and five other physician groups submitted a letter to CMS Acting Administrator Andrew Slavitt urging CMS to adopt unique Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes) for biosimilars. We believe that CMS must take an approach that is consistent with FDA’s proposal for distinguishable names and adopt unique HCPCS J-codes for each biosimilar.  Read More ›

September 2, 2015

Physician Groups Urge CMS: Follow FDA Lead on Unique Names for Biological Medicines

Unique CMS Billing Codes for Biosimilars Would Support Sound Prescribing and Patient Safety. 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BPC Statement on FDA Draft Guidance entitled “Nonproprietary Naming of Biological Products”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 ›

August 27, 2015

BPC Statement on FDA Draft Guidance entitled “Nonproprietary Naming of Biological Products”

Biosimilars are not generics and the Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (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 ›

July 29, 2015

AGA Releases Physician Biosimilars Survey Results

The American Gastroenterological Association (AGA) released the findings of a national survey of gastroenterologists on biologics and biosimilars. The survey of 180 AGA members examined their prescribing practices and explored their views on the safety and quality standards needed as biosimilars enter the U.S. marketplace. Specifically, 40 percent of respondents felt they were extremely or very familiar with biosimilars while 51 percent were somewhat or slightly familiar with biosimilars. Additionally, 67 percent of respondents favored a policy whereby the FDA would not allow indication extrapolation in the approval of biosimilars for inflammatory bowel diseases relative to a policy that allowed for indication extrapolation. Read More ›

July 16, 2015

AfPA Infographic: Transparent Biosimilar Labeling - Physicians Need Clear Data

AfPA Infographic: Transparent Biosimilar Labeling - Physicians Need Clear Data Read More ›

July 1, 2015

CSRO Releases Physician Biosimilars Survey Results

The Coalition of State Rheumatology Organizations (CSRO), released findings of a national survey of rheumatologists that explored perceptions of biosimilar medicines. They survey revealed rheumatologists have concerns about the biosimilars approval process and overwhelmingly support clearer regulatory standards for these new therapies. Specifically, 75 percent of rheumatologists surveyed say the FDA should mandate that biosimilars have a different non-proprietary name than the innovator biologic medicine and more than 82 percent of respondents believe that the FDA approval standards for designating a biosimilar as "interchangeable" must be very rigorous to ensure patient safety. Read More ›

May 21, 2015

Physician Groups Urge FDA to Ensure Patient Safety With Greater Transparency in Biosimilar Labeling

On May 21st, the Biologics Prescribers Collaborative and seven other groups representing a broad spectrum of physicians who prescribe biologics sent a letter to FDA Commissioner Ostroff underscoring the need to ensure that biosimilar product labeling contains all needed data for physicians to make appropriate prescribing decisions for their patients. Read More ›