Resources

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

Latest Resources

February 13, 2017

Physician Groups on FDA Biologics Naming Guidance; Disappointed in ‘Random’ Suffix

BPC applauds the FDA for issuing final guidance calling for distinguishable names for all biologic medicines. However, as the BPC has voiced to FDA, we remain concerned with “random” suffixes called for in the guidance. As physicians who routinely prescribe biologic medicines, we believe a memorable suffix is needed. One that reflects the manufacturer of the medicine is immediately recognizable and would facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer and that manufacturer's mandated reporting to FDA. Read More ›

January 16, 2017

FDA Releases Final Guidance for ‘Nonproprietary Naming of Biological Products’

The U.S. Food and Drug Administration (FDA) on Thursday released its final guidance for industry on the "Nonproprietary Naming of Biological Products." The move generated positive reaction from physician groups and other health professionals.   Read More ›

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 ›

November 9, 2016

Importance of “Meaningful” Suffixes

Meaningful suffixes are important in medicine. That’s why 80% of doctors prefer them for biosimilar naming as well. The FDA is considering naming biosimilar medicines with a random code versus a more recognizable name. In a recent SERMO* poll, representing over 500 physicians across multiple specialties, 80% of physicians prefer a “meaningful suffix.” Physician groups across the country call for biosimilar names that are easily distinguished and recognized.  *SERMO is the largest global social network exclusively for doctors. Read More ›

October 18, 2016

BPC Supports FDA on BsUFA Proposal, Raises Guidance Timing Concerns

BPC supports FDA's continuing careful deliberation on biosimilar-related issues along with your expert and diligent review of medical products. In particular, the Collaborative is pleased that FDA has stated that it will make decisions on a case-by-case basis until it has the knowledge to impose a comprehensive regulatory framework for the approval and safe use of biosimilars. BPC realizes that this is a time and resource intensive process. Therefore, we applaud FDA for the proposed recommendations being submitted for the BsUFA reauthorization for FY 2018-2022 and for taking the opportunity to set aggressive drug review timelines and goals, refine existing activities and remove provisions that are no longer needed. 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 ›

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 ›