Tony Hagen is senior managing editor for The Center for Biosimilars®.
The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.
Shanghai Henlius Biotech said its adalimumab biosimilar candidate HLX03 has been approved by China’s National Medical Products Administration for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
This marks the third biosimilar that Henlius has developed and won approval for in China. The others are rituximab (HLX01) and trastuzumab (HLX02, Zercepac) biosimilars. Zercepac also has European marketing authorization.
Henlius said that it conducted numerous head-to-head trials of HLX03 and the adalimumab reference product (Humira), and that clinical, nonclinical, and analytical studies demonstrated HLX03 is highly similar to Humira. HLX03 will be commercialized in China by Wanbang Biopharma, a subsidiary of Fosun Pharma.
“The approval of this product marks the expansion of the company’s commercial pipeline into the field of autoimmune diseases, and the scope of patients that can benefit from Henlius products is further broadened,” Wenjie Zhang, CEO and president of Henlius, said.
A month ago, Henlius reported positive phase 3 clinical study data for a bevacizumab biosimilar candidate (HLX04).