Prestige’s HD201, a Biosimilar to Herceptin, Accepted for Review in Europe for HER2-positive BC

Prestige’s HD201, a Biosimilar to Herceptin, Accepted for Review in Europe for HER2-positive BC
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by Prestige BioPharma for HD201, its lead biosimilar to Genentech's Herceptin (trastuzumab). 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
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