- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Shanghai Henlius Biotech Gains China's Approval for Adalimumab Biosimilar
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).
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
