FDA Approves Hercessi, a Biosimilar to Herceptin
Accord BioPharma, Inc., announced that the FDA has approved Hercessi™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
- Hercessi and its reference product, Herceptin (trastuzumab), are highly similar in terms of efficacy, safety, and quality. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.
- The safety profile of Hercessi has been shown to be consistent with the safety profile for the reference
product Herceptin. The data demonstrates that there are no clinically meaningful differences between Hercessi and Herceptin in the populations studied and support biosimilarity between the two therapies. - Hercessi was approved by the FDA at a dosage of 150mg. A 420mg-strength version of Hercessi is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024.
Source: Accord BioPharma
