Biosimilar Leaders Compliment Pfizer For Calling Out Fellow Innovators, But Should FDA Play A Role To Dispel Misinformation?
Executive Summary
Industry speakers at AAM's GRx and Biosims conference discussed whether FDA should play a role, or whether education should fall solely on the shoulders of sponsors.
You may also be interested in...
FDA Considering Biosimilars ‘Guardrails’
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
Biosimilars: US FDA Considering ‘Guardrails’ To Prevent Misinformation
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
Biosimilars: Some Patient And Prescriber Groups Appear To Warm Up To Arbitrary Suffixes
Patient and prescriber groups were largely opposed to suffixes for the nonproprietary names of biological products being devoid of meaning when the US FDA first published its nomenclature policy, although a few of these groups may be signaling less of a worry than they once had.