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).
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.