On June 1, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ( European Medicines Agency, EMA) issued a favorable opinion that recommended the market for the HLX02 biosimilar (trastuzumab injection) for the treatment of early HER-2-positive breast cancer, HER2-positive metastatic breast cancer and previously untreated HER-2-positive metastatic cancer Contains adenocarcinomas of the stomach or the transition area of the esophagus into the stomach (Press release, Shanghai Henlius Biotech, JUN 1, 2020, View Source;816056005.html [SID1234560743]). According to the EMA-CHMP summary of this positive opinion, HLX02 is the reference product Herceptin (Trastuzumab) very similar. Data show that HLX02 is comparable to Herceptin in terms of quality, safety and effectiveness .
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HLX02 is a monoclonal biosimilar antibody (mAb) developed and manufactured by Henlius in accordance with biosimilar guidelines and will be marketed and marketed by Accord in Europe. The CHMP’s opinion is now being reviewed by the European Commission. A regulatory decision is expected over the next two to three months. As soon as a license is granted , a centralized marketing authorization is granted for all EU member states, Iceland, Norway and Liechtenstein .
Dr. Scott Liu , co-founder and CEO of Henlius , commented: "We are proud of CHMP’s favorable opinion on Henlius, as is the fact that Henlius’ capabilities in developing and manufacturing biological products are recognized by an international drug agency. We look forward to the launch of HLX02 as an alternative, high quality and affordable treatment option for patients with HER-2 positive breast cancer and gastric cancer. We will continue to work with Accord, make HLX02 more available in Europe and other regions, and continue to strive to support patients around the world. "
Dr. James Burt , Executive Vice President of Accord Europe and MENA added: "We are committed to providing oncology patients with access to safe, inexpensive drugs. The CHMP’s positive opinion is due to our in-depth expertise and our extensive portfolio of oncological therapies. Our agreement with Henlius reflects our longstanding commitment to biopharmaceutical development, research and manufacturing. "