Boehringer Secures FDA Approval For High-Concentration Cyltezo – But Without Interchangeability
The Formulation Did Not Receive The Designation Despite Meeting Requirements
Executive Summary
Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.