Tony Hagen is senior managing editor for The Center for Biosimilars®.
Shanghai Henlius Biotech received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization in 2 to 3 months.
The European Medicines Agency (EMA) has recommended marketing authorization for Shanghai Henlius Biotech’s trastuzumab biosimilar candidate HLX02 for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and previously untreated HER2-positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.
Following a review that began in June 2019, the EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that the biosimilar candidate is highly similar in quality, safety, and efficacy to the reference product (Herceptin).
A final regulatory decision for marketing authorization from the European Commission is anticipated in 2 to 3 months following review of CHMP’s opinion. A positive decision would lead to marketing authorization in all EU member states and Norway, Iceland, and Liechtenstein, which are members of the European Free Trade Association, a group of non-EU European countries.
Positive clinical data supporting biosimilarity of HLX02 to the reference product were released in November 2019. The biosimilar monoclonal antibody candidate will be marketed in Europe by Accord Healthcare Limited.
“We are very proud to receive CHMP’s positive opinion for HLX02,” said Scott Liu, cofounder and CEO of Henlius. “We look forward to launching HLX02 to provide an alternative high-quality and affordable treatment option for patients with HER2 positive breast cancer and gastric cancer.”
Henlius’ current product pipeline spans 20 monoclonal antibodies. The company launched a rituximab biosimilar (HLX01) in China last year and has trastuzumab (HLX02) and adalimumab (HLX03) biosimilar candidates under New Drug Application review. It also has a bevacizumab biosimilar (HLX04) undergoing clinical trials in China.
Henlius has also developed a mAb checkpoint inhibitor therapy (HLX10) for the treatment of advanced solid tumors and chronic hepatitis B infections. The drug is undergoing trials as monotherapy in the United States, Taiwan, and China and is intended, in particular, for tumors that show little response to anti—PD-1/anti–PD-L1.
Phase 3 trials of HLX10 in combination with chemotherapy are underway for the treatment of locally advanced/metastatic esophageal squamous-cell carcinomas, squamous non—small cell lung cancer, and extensive-stage small cell lung cancer.
Henlius and Accord signed a deal in June 2018 that provided Accord with rights to market HLX02 in Europe, the Middle East, North Africa, and certain countries in the Commonwealth of Independent States, which is comprised of post-Soviet states in Eurasia. Accord specializes in the distribution of generics and biosimilars and has a sales presence in 80 countries.
"We are committed to ensuring oncology patients get access to safe, cost effective medicines and this CHMP positive opinion builds on our established expertise and extensive oncology treatment portfolio,” said James Burt, executive vice president of Accord.