Resources

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

Press Releases

May 19, 2017

Physician Groups Applaud FDA for Interchangeability Draft Guidance, Urge for Robust Data

On Friday, May 19, 2017, six groups representing a broad spectrum of biologic prescribers – AfPA, AACE, ACR, AGA, BPC and CSRO – submitted a comment to FDA commending the agency for its thoughtful draft guidance entitled “Considerations in Demonstrating Interchangeability with a Reference Product.” BPC believes that, once available, this guidance will ensure prescribers have more of the information necessary to make informed decisions with their patients. As FDA continues to develop the draft guidance, BPC urges the agency to promote transparency and patient safety by paying particular attention to the data, including robust clinical switching studies, required to demonstrate interchangeability. Read More ›

August 2, 2016

Physician Groups Applaud FDA on Biosimilar Labeling, Urge For Greater Transparency To Ensure Patient

On Tuesday, August 2, 2016, eight groups representing a broad spectrum of biologic prescribers – AfPA, AACE, ACR, AGA, BPC, CSRO, Endocrine Society, and NASPGHN – commented on the U.S. Food and Drug Administration’s (FDA) draft guidance “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability”, commending the agency on acknowledging the distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity. 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 ›

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 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 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 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 ›

May 21, 2015

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

Following Approval of the First Biosimilar in the U.S., Physician Groups Urge FDA to Give Full Consideration to Inclusion of Critical Information Needed by Physicians. Read More ›

March 26, 2015

Patient Advocates, Physicians, Pharmacists Unite to Support Unique Biosimilars Naming Policy

With FDA's Approval of the First Biosimilar in the U.S., Groups Urge OMB to Work with FDA to Finalize Critical Naming Policy Supporting Patient Safety. Read More ›