EMA Notifies Prestige Biopharma of "Negative Opinion" on Herceptin Biosimilar

[Asia Economy Reporter Lee Chun-hee] Prestige BioPharma announced on the 20th that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) delivered a negative opinion on the marketing authorization application for 'HD201,' a biosimilar of the breast and gastric cancer anticancer drug 'Herceptin' developed by the company, on the 19th (local time).

Prestige BioPharma had applied for marketing authorization of HD201 to the EMA in May 2019. The company stated, "CHMP has delivered a negative opinion," and added, "We will correct and supplement the details as soon as the relevant information is confirmed."

Prestige BioPharma plans to request a re-examination of the marketing authorization for HD201 from the EMA. Currently, HD201 has also been submitted for marketing authorization to the Ministry of Food and Drug Safety in Korea and the Canadian Health Authority, in addition to the EMA.

Earlier in March, Prestige BioPharma announced that the results of a Phase 3 clinical trial of HD201 involving 502 patients with HER2-positive stage 2-3 breast cancer in 12 countries including France and Spain showed that the difference between the HD201 treatment group and the Herceptin treatment group was -3.8%, meeting the pre-established "equivalence margin." For the secondary endpoint, the breast pathological complete response rate (bpCR), the difference between the two treatment groups was -0.9%, confirming equivalence, and equivalence was also confirmed for the objective response rate (ORR). Overall survival (OS) and event-free survival (EFS) analyzed over three years were also reported to confirm equivalence.