Henlius Biotech Gets EC Marketing Approval for Zercepac

The European Commission (EC) has approved the marketing of the trastuzumab biosimilar Zercepac, developed by Shanghai Henlius Biotech and set to be marketed by Accord Healthcare, according to information released by the companies and the EC.

Zercepac (HLX02) is indicated for the treatment of early breast cancer following surgery or chemotherapy and radiotherapy; metastatic breast cancer alone or in combination with other medicines, such as paclitaxel or docetaxel or aromatase inhibitors; and metastatic gastric cancer in combination with cisplatin and either capecitabine or fluorouracil.

The biosimilar trastuzumab is intended for use only in cancers that are HER2-expressing, which is the case in about 25% of breast cancers and 20% of gastric cancers. The newly approved biosimilar references Herceptin.

Henlius is based in Shanghai, China, with research and development activities in California; and Accord is based in Ahmedabad, India, with a suburban office in North Harrow outside London, England.

International Standing for Henlius

Henlius has sought to develop international standing as a biosimilar company and in its statement today, officials said this approval demonstrates that the company is achieving that objective. “The approval of Zercepac in the EU is a significant milestone of our global strategy,” said Scott Liu, co-founder and CEO of Henlius. “This achievement announces that our capability in the development and manufacturing of biologics has reached international standards. In the future, Henlius will provide more high-quality biologics as new treatment options to benefit patients worldwide.”

“Henlius strictly followed the [China National Medical Products Administration] and [European Medicines Agency] guidelines and has [done] multiple head-to-head comparisons between Zercepac…and the reference trastuzumab, including comparative quality studies, preclinical studies, a phase 1 clinical study and a global multi-center phase 3 clinical study. [The] manufacturing site of Zercepac and its quality management system have obtained EU [Good Manufacturing Practices] certificates,” the company said.

For Accord, the trastuzumab product marks the company’s first monoclonal antibody and therefore raises the company’s profile in the world of complex biologics, according to Paul Tredwell, vice president of Specialty Brands for Accord.

“Zercepac is an exciting new addition to our growing oncology portfolio, which now provides access to over 30 high-quality, cost-effective oncology treatments to patients across Europe,” he said.