Resources

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

Latest Resources

February 3, 2016

Comment to the Arthritis Advisory Committee regarding: BLA 125544

The BPC submitted a comment to the Arthritis Advisory Committee to share our perspective on issues critical for the safe use of biosimilars, as well as other biologics as they considered BLA 125544 Read More ›

February 3, 2016

Biosimilar Billing Code Infographic

Per previous comments to CMS, the Biologics Prescribers Collaborative wishes that each biosimilar would receive its own unique payment rate and HCPCS code. This graphic depicts that in order to trace side effects to their source, a unique billing code is required for each biological medicine. As physicians who make complex medical decisions daily, we are committed to principles of patient-centered care and a clinically-sound prescribing process for biological products, including biosimilars. The current CMS policy of assigning a single HCPCS billing code and reimbursement rate for all biosimilars of a single reference product seriously jeopardizes these principles, undermining innovation, science and safety. Read More ›

January 28, 2016

BPC Statement on WHO Biosimilar Naming Decision

Biologics Prescribers Collaborative (BPC) applauds the World Health Organization (WHO) for acknowledging the need for biosimilars to be assigned a distinguishable qualifier in its biosimilar naming decision, or Biological Qualifier scheme, for the Programme on International Nonproprietary Names (INN). As FDA works to finalize its naming guidance, BPC reiterates our support for FDA’s proposal that all biological products bear a distinguishable four-letter suffix but urge the agency to also ensure that the suffixes be meaningful. Read More ›

January 21, 2016

Congressional Doctors Caucus Urges FDA to Consider Physician Input on Biosimilar Labeling

It’s time for clarity about the prescribing information that accompanies biosimilar medications, the U.S. House Doctors Caucus told the FDA in a Dec. 21, 2015 letter. What’s more, signers of the letter argue, the FDA should “solicit and consider” physician viewpoints when crafting the long-anticipated regulatory guidance. Read More ›

December 22, 2015

BPC’s Wishes for Biologics in 2016

2015 marked a pivotal year for biosimilars, offering those suffering from chronic illness increased patient access to new therapeutic options. As we look forward to the upcoming year, Biologics Prescribers Collaborative resolves to continue our commitment to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients. Read More ›

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 ›