Prestige Bio's Herceptin biosimilar proves equivalence in clinical trials

Prestige Biopharma, a South Korean biopharmaceutical developer, said on Tuesday that the final analysis of phase 3 clinical trial on the anti-cancer biosimilar (biopharmaceutical generic drug) HD201 proved its equivalence to the original drug Herceptin.

HD201 is Prestige Biopharma's first biosimilar and is used to treat breast cancer and metastatic gastric cancer.

The company conducted clinical trials on 502 breast cancer patients in 12 countries from Feb. 2018 to January last year.

As a result of tracking the progress for about three years with all clinical patients, the company explained that HD201 showed excellent long-term efficacy and safety. The three-year overall survival ratio (the percentage of patients surviving after a certain period of time after treatment) was 95.6% in the HD201-administered group, which was almost equivalent to 96% in the Herceptin-administered group.

The clinical results were published in the international cancer open-access journal BMC (BioMed Central) Cancer.

Write to Jeong Min Nam at peux@hankyung.com