Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US
Executive Summary
The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.
You may also be interested in...
Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.
Biosimilars Forum’s New Executive Director Faces Down Challenge Of Interchangeability Confusion
Juliana Reed, who just moved from Pfizer to head the trade group, hopes scientific advances will eventually eliminate the need for the interchangeability designation, but for now the association is educating stakeholders in preparation for the 2023 launch of Humira biosimilars.
FDA And FTC Offer Advice On Biosimilar Barriers
Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.