Resources

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

Latest Resources

December 9, 2015

Physician Groups Express Concerns to Congress on CMS Biosimilar Billing Code Decision

On December 9th, BPC and five other physician groups submitted a letter Senator Orrin Hatch expressing our serious and continuing concerns with the CMS decision to place biosimilars of a single reference product into one Healthcare Common Procedure Coding System (HCPCS) code. These physician groups urged Members of Congress to direct CMS to adhere to current law that states that the calculation for reimbursing biosimilars shall be made separately, strongly implying that each biosimilar should have its own unique payment rate and HCPCS code. Read More ›

December 9, 2015

Physician Groups Urge Congress to Direct CMS to Adopt Unique Billing Codes for Biosimilars

On Wednesday, December 9, 2015, six groups representing a broad spectrum of physicians who prescribe biologics – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative, and Coalition of State Rheumatology Organizations– sent a letter to Senator Orrin Hatch (R-UT), urging Congress to direct Centers for Medicare & Medicaid Services (CMS) to adhere to current law that states that the calculation for reimbursing biosimilars shall be made separately, strongly implying that each biosimilar should have its own unique payment rate and HCPCS code.  Read More ›

October 27, 2015

Physician Groups Argue Against ‘Random’ Suffix: Applaud FDA for Distinguishable Biologics Naming

As members of the Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, we support sound policies that promote the safe use of biologics, including biosimilars, for all patients. We applaud the Food and Drug Administration (FDA) for recognizing in its “Nonproprietary Naming for Biologic Products” (“draft guidance”), that each biological product needs a distinguishable non-proprietary name. Read More ›

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 ›