Resources

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

Letters

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 ›

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 ›

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 ›

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 ›

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 ›

September 2, 2015

Physician Groups Urge CMS to Adopt Unique Billing Codes (J-codes) for Each Biosimilar

On September 1st, BPC and five other physician groups submitted a letter to CMS Acting Administrator Andrew Slavitt urging CMS to adopt unique Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes) for biosimilars. We believe that CMS must take an approach that is consistent with FDA’s proposal for distinguishable names and adopt unique HCPCS J-codes for each biosimilar.  Read More ›

May 21, 2015

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

On May 21st, the Biologics Prescribers Collaborative and seven other groups representing a broad spectrum of physicians who prescribe biologics sent a letter to FDA Commissioner Ostroff underscoring the need to ensure that biosimilar product labeling contains all needed data for physicians to make appropriate prescribing decisions for their patients. Read More ›

March 24, 2015

Patient Advocates, Physicians, Pharmacists Urge OMB to Work with FDA to Finalize Naming Policy

Five advocacy groups representing a broad spectrum of patients, providers, and pharmacists sent a letter to Office of Management and Budget (OMB) Director Shaun Donovan urging OMB to work with the U.S. Food and Drug Administration (FDA) to issue a unique naming policy for biosimilars.  Read More ›

December 18, 2014

Follow-up Biologics Prescribers Letter to FDA on Distinguishable Naming

On December 18, the Biologics Prescribers Collaborative sent a second letter to FDA Commissioner Hamburg advocating for distinguishable naming for biosimilars. Read More ›

August 14, 2014

Biologics Prescribers Letter to FDA on Distinguishable Naming

On August 14, the Biologics Prescribers Collaborative sent a letter to FDA Commissioner Hamburg advocating for distinguishable naming for biosimilars.  Read More ›