Resources

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

Latest Resources

September 23, 2016

BPC Statement on FDA Approval of Adalimumab Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)'s decision today to approve Amjevita, the fourth biosimilar in the United States and an Amgen biosimilar to AbbVie’s Humira (adalimumab). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies. BPC appreciates FDA's continuing careful deliberation on biosimilar-related issues, however the decision approve a fourth biosimilar without FDA finalizing their decisions on naming, labeling or interchangeability policies for biologics does cause concern and creates confusion. Read More ›

August 31, 2016

BPC Statement on FDA Approval of Etanercept Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)'s decision yesterday to approve the third biosimilar in the United States, Sandoz biosimilar to Amgen’s Enbrel (etanercept). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies. BPC appreciates FDA's continuing careful deliberation on biosimilar-related issues, however the decision approve a third biosimilar without FDA finalizing their decisions on naming, labeling or interchangeability policies for biologics does cause concern and creates confusion. Read More ›

August 2, 2016

BPC Statement on FDA’s “Labeling for Biosimilar Products” Draft Guidance

As members of the Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, we welcome the availability of biosimilars in the U.S. Biosimilars will provide greater access to more therapeutic options for the thousands of patient who rely on biologic medicines. We thank the U.S. Food and Drug Administration (FDA) for its thoughtful draft guidance “Labeling for Biosimilar Products” that makes important distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity. We believe the label of a biosimilar product should be transparent and facilitate access to data used in support of the biosimilar application. ​ 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 Commend Congress: FDA Should Be Authority on Biologics

On July 13th, BPC and five affiliated groups submitted a letter to Chairman Alexander and Ranking Member Murray commending their bipartisan sponsorship of Section 11 of S. 2700. BPC and the undersigned organizations strongly support the provisions of S. 2700 (as amended) that assure full FDA authority over the identity (name) and quality standards for biologic products, including biosimilars. Absent this assurance, the unique regulatory framework Congress designed exclusively for the approval and safe use of biosimilars could be severely undermined.   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 ›

May 3, 2016

Biosimilar Naming: Distinguishable or Disingenuous?

A guest post from Robert Yapundich, M.D. and Gregory Schimizzi, M.D. Read More ›

April 12, 2016

The Biosimilar Promise: An Introduction for Prescribers

The biosimilars age has arrived with the promise of an expanding array of therapeutic options for patients and physicians battling serious diseases and conditions. As prescribers of biologics, we believe that realizing the biosimilar promise requires awareness of the differences between biosimilars and generics, and among biologics themselves, as well as an understanding of the distinctive therapeutic choices they represent. This introductoary handbook provides an overview of the key issues. Read More ›

April 12, 2016

AfPA Summit on Biologics and Biosimilars

Video highlights from the National Policy & Advocacy Summit on Biologics and Biosimilars Read More ›

April 6, 2016

BPC Statement on FDA Approval of Infliximab Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)'s decision on April 5, 2016 to approve the second biosimilar in the United States, Celltrion's biosimilar to Janssen Biotech, Inc.'s Remicade(tm) (infliximab). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies. BPC appreciates FDA's continuing careful deliberation on biosimilar-related issues, however the decision to use a four letter randomized suffix in the naming of the biosimilar has raised many concerns. Patient safety must be prioritized to ensure the safe use of biosimilars, and BPC believes that pharmacovigilence is best achieved through the use of memorable and distinguishable non-proprietary names for all biologics. Read More ›