EMA Recommends Denying Marketing Authorization for Prestige BioPharma’s TUZNUE and HERVELOUS (trastuzumab) (UPDATE – 5/27/2022)

European Medicines Agency

On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and its duplicate HERVELOUS, proposed trastuzumab biosimilars of Roche’s HERCEPTIN. TUZNUE and HERVELOUS are intended for the treatment of HER2-positive forms of breast cancer and gastric cancer. Prestige BioPharma has entered into agreements to distribute, market, and sell TUZNUE in selected European countries (including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland, and Austria) and Israel, as well as agreements to commercialize HERVELOUS in Central and Eastern Europe.

In March, we reported that Prestige BioPharma had announced positive safety and efficacy results in a Phase III study for HD201. However, according to the EMA opinions, the main reason for refusing the marketing authorization was that “the manufacturing process of the medicine used during clinical testing differed from the process for commercial production of the medicine,” and “[a]s a result, the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine.”

The Korea Biomedical Review (KBR) reports that Prestige stated “that the company changed the manufacturing process of HD201 twice during a Phase 3 study of the biosimilar.”  According to KBR, a Prestige official stated that the process was changed once “to keep up with the product drift of the original drug Herceptin and another time, for upscaling the manufacturing to commercial use.”

Prestige BioPharma can apply for re-examination to the EMA within 15 days of receiving the opinions.

UPDATE (5/27/2022): On May 23, 2022, Prestige BioPharma announced that its CEO Dr. Lisa S. Park and COO Michael J. Kim purchased KDR 138,206 shares of the company’s stock. Dr. Park commented, “We expect this in-house purchase would increase shareholder value and push up the share price. Prestige Biopharma will do its utmost to promote future value of the company. … Even though we are disappointed by the EMA’s decision, we are still confident with HD201 and its value, thus focus on preparing for the EMA’s re-examination for HD201 thoroughly.”