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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).
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
