Resources

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

Position Statements

January 12, 2017

BPC Statement Applauding FDA for Distinguishable Biologics Naming; Disappointed in ‘Random’ Suffix

The Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for issuing final guidance calling for distinguishable names for all biologic medicines. This policy is an important win for patients and physicians because distinguishable naming is essential for pharmacovigilance, patient safety and transparency. However, as the BPC has voiced to FDA, we remain concerned with  “random” suffixes called for in this guidance. Read More ›

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BPC Statement on FDA’s “Labeling for Biosimilar Products” Draft Guidance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

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 ›

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 ›