EMA recommends denying marketing authorization for Prestige BioPharma’s TUZNUE and HERVELOUS (trastuzumab)

On May 19, 2022, the European Medicines [European Medicines Agency] The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued opinions recommending the refusal of marketing authorization for HD201 from Prestige BioPharma Ltd., TUZNUE and its duplicate HERVELOUS, biosimilars of trastuzumab offered by HERCEPTIN from Roche. 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 certain European countries (including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria) and Israel , as well as agreements to market HERVELOUS in Central and Eastern Europe.

In March, we reported that Prestige BioPharma announced positive safety and efficacy results in a Phase III study for HD201. However, according to EMA notices, the main reason for denial of marketing authorization was that “the manufacturing process of the drug used in clinical trials differed from the commercial production process of the drug” and “[a]Therefore, 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 said “the company changed the manufacturing process for HD201 twice during a phase 3 study of the biosimilar.” According to KBR, a Prestige official said the process was changed once “to follow product drift from the original drug Herceptin and another time to expand manufacturing for commercial use.”

Prestige BioPharma may request a review from the EMA within 15 days of receiving the notices.

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