#FDA

Education

Updated Handbook The Biosimilar Promise: An Introduction for Prescribers

September 2018 Physician Survey Findings: Interchangeability Standards and Physician Confidence

Whitepaper The State of Biosimilars Policy: A White Paper from Biologics Prescribers Collaborative

Educational Video The Path to Approval

Policy & Issues

May 19, 2017 Physician Groups Comment on FDA Interchangeability Guidance: Urge for Robust Data

February 13, 2017 Physician Groups on FDA Biologics Naming Guidance; Disappointed in ‘Random’ Suffix

January 12, 2017 BPC Statement Applauding FDA for Distinguishable Biologics Naming; Disappointed in ‘Random’ Suffix

October 18, 2016 BPC Supports FDA on BsUFA Proposal, Raises Guidance Timing Concerns

September 23, 2016 BPC Statement on FDA Approval of Adalimumab Biosimilar

August 31, 2016 BPC Statement on FDA Approval of Etanercept Biosimilar

August 2, 2016 BPC Statement on FDA’s “Labeling for Biosimilar Products” Draft Guidance

August 2, 2016 Physician Groups Applaud FDA on Biosimilar Labeling, Urge For Greater Transparency To Ensure Patient

June 13, 2016 Physician Groups Commend Congress: FDA Should Be Authority on Biologics

Press Releases

September 4, 2018 Biologics Prescribers Collaborative to Speak at FDA Hearing on Biosimilars

August 1, 2018 BPC Responds to FDA Biosimilars Action Plan, Reiterates Support of Scientifically-based, Patient-centered Regulatory Standards

May 19, 2017 Physician Groups Applaud FDA for Interchangeability Draft Guidance, Urge for Robust Data

August 2, 2016 Physician Groups Applaud FDA on Biosimilar Labeling, Urge For Greater Transparency To Ensure Patient

June 13, 2016 Physician Groups Support Bill Providing Authority to FDA on Biologics

October 27, 2015 Physician Groups Applaud FDA for Distinguishable Naming; But Argue Against ‘Random’ Suffix

August 27, 2015 BPC Statement on FDA Draft Guidance entitled “Nonproprietary Naming of Biological Products”

May 21, 2015 Physician Groups Urge FDA to Ensure Patient Safety With Greater Transparency in Biosimilar Labeling

March 26, 2015 Patient Advocates, Physicians, Pharmacists Unite to Support Unique Biosimilars Naming Policy

Uncategorized

Approval Chart Index of Approved Biosimilars

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