Posted by Cyclodextrin-based super-generics represent enhanced versions of reformulated drug products, offering improved performance and patient outcomes usually developed/marketed by a generic company. Herein, we present a unique case where the originator itself introduces a new, optimized composition with cyclodextrin intended to replace its own original formulation.
Theratechnologies Inc., a commercial-stage biopharmaceutical company, announced on 25 March 2025 that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for their HPBCD-enabled formulation of tesamorelin (N-terminally modified compound based on 44 amino acids sequence of human growth hormone–releasing hormone having M=5.1 kDa) for injection [1]. The Company now commercializes the new formulation under the tradename EGRIFTA WR™.
Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The new formulation, EGRIFTA WR™, is a daily injectable but only needs weekly reconstitution. It requires less than half the administration volume as the old formulation, now sold in the U.S. as EGRIFTA SV®, which is reconstituted daily. Pharmacokinetic studies have shown bioequivalence of EGRIFTA WR™ to the old formulation of tesamorelin for injection.
The old formulation contains histidine, mannitol, polysorbate 20 and sucrose as excipients, whereas the “super-originator” product comprises hydrochloric acid, hydroxypropyl betadex (HPBCD), mannitol and sodium hydroxide [2].
The new formulation, which is patent protected in the U.S. until 2033, is set to replace EGRIFTA SV®, well exemplifying how a cyclodextrin can enhance the life-cycle of a valuable active pharmaceutical ingredient.