Resources

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

Latest Resources

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 ›

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 ›

March 9, 2015

HOPA Statement on First Biosimilar Product Approved in the United States

(March 2015): The Hematology/Oncology Pharmacy Association (HOPA) is encouraged by the Food and Drug Administration’s (FDA) approval of the first biosimilar product, Zarxio (filgrastim-sndz), in the United States, but strongly urges the FDA to develop a naming policy for approved biosimilars. HOPA believes that naming is important to avoid prescribing and dispensing errors and that biosimilars must be able to be easily tracked to monitor safety and quality. Read More ›

March 6, 2015

Biologics Prescribers Collaborative (BPC) Statement on FDA Approval of Filgrastim Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)’s decision today to approve the first biosimilar in the United States, Sandoz’s biosimilar to Amgen’s Neupogen™ (filgrastim). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies. Read More ›

March 6, 2015

FDA News Release: FDA approves first biosimilar product Zarxio

March 6, 2015 - The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Read More ›

January 7, 2015

FDA Oncologic Drugs Advisory Committee Meeting

On January 7, the FDA Oncologic Drugs Advisory Committee convened the first advisory committee meeting to consider a biosimilar application, which was filed by Sandoz for its biosimilar to Neupogen™ (filgrastim).  Committee members voted unanimously to recommend that the FDA approve the Sandoz application. 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 ›

September 1, 2014

FDA Purple Book Release

In September 2014, FDA released its “Purple Book,” a list of the biological products, including biosimilars and interchangeable biological products—licensed by FDA. 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 ›