US FDA Outlines Biosimilar First Interchangeability Policy … In A Memo
Executive Summary
Stakeholders may be irked that the agency chose to release a memo on its interpretation of the first interchangeable exclusivity law before issuing formal guidance.
You may also be interested in...
Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says
While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.
Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says
While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.
Interchangeable Exclusivity: Pfizer To Rival Boehringer On Humira Biosimilar After US FDA Decision
FDA decision ends Boehringer Ingelheim’s exclusivity for interchangeable biosimilar of Humira after just a few months. Pfizer reveals pricing and launch information for its Abrilada version of adalimumab.