Like Herceptin, HD201 is indicated for the treatment of women with HER2-positive breast cancer. Prestige’s lead biosimilar candidate also is indicated for treating patients with HER2-overexpressing advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
A biosimilar is a nearly identical, yet lower-priced version, of an original brand medication. Pharmaceutical companies may start producing biosimilars when the patent of the original brand product expires, after obtaining a license from its manufacturer.
According to top-line data from two ongoing clinical trials — the Phase 1 TROIKA-1 trial (NCT03776240) and the Phase 3 TROIKA trial (NCT03013504) — the efficacy, safety, and tolerability profiles of HD201 are highly similar to those reported for Herceptin when administered to healthy volunteers and patients with ea