Han Da Yuan® (Adalimumab Injection) Presented at the 27th National Academic Conference on Dermatology and Venereology of the Chinese Medical Association
On June 19, 2021, the 27th Annual Meeting of Chinese Society of Dermatology (CSD) of Chinese Medical Association (CMA) was successfully held in Xi'an. During the meeting, a symposium on Han Da Yuan® (Adalimumab Injection), Fosun Pharma's first biologics indicated for autoimmune disease, was grandly broadcast. For the symposium, Professor Xinghua Gao, the next president of the CMACSD and the vice president of the First Hospital of China Medical University, was invited to serve as the chairman, and Professor Yuzhen Li, from the Second Affiliated Hospital of Harbin Medical University, also a standing committee member of the CMACSD, was invited to serve as the speaker.
Professor Xinghua Gao
Professor Yuzhen Li interpreted from three aspects: the brief introduction to biosimilars, the application of adalimumab in psoriasis, and the evidence-based interpretation of Han Da Yuan® in China for psoriasis. First, she distinguished biosimilars from innovator drugs, and explained that the difference between a biosimilar and its reference drug is equivalent to the difference among batches of a same biological drug. Then Professor Li mentioned that: biosimilars are more and more recognized both in China and abroad, and the development of biologics in China is also very rapid. Biosimilars allow patients to enjoy high-quality and low-cost treatment. As a representative biosimilar to adalimumab, Han Da Yuan® is sold currently at RMB899/bottle, making the price of adalimumab lower than RMB 1000, and bringing great economic benefits for the patients.
Professor Li also shared the action characteristics and mechanism of adalimumab: it exerts clinical efficacy by specifically binding to TNF-a resulting in blockade of the interaction between the latter with TNF receptors on the surface of P55 and P75. She said that: many clinical studies in China and abroad have proved that adalimumab can lastingly control skin lesions including those in different psoriasis populations, and confirmed the efficacy and safety of adalimumab in long-term use.
Then, Professor Li pointed out that: with reference to the innovator adalimumab, Han Da Yuan® was developed in strict accordance with the "Technical Guidelines for the R&D and Evaluation of Biosimilar Drugs (Interim)"; head-to-head comparative studies, including those for pharmaceutical, non-clinical and clinical trials, have been performed between Han Da Yuan® and the reference product, proving high similarity in terms of quality, safety and efficacy. Different from the indications of other adalimumab biosimilars currently launched in China, psoriasis was selected in clinical phase III comparative study for Han Da Yuan®. It is the first domestic adalimumab biosimilar with phase III trial in Chinese psoriasis patients, accumulating more valuable clinical evidence and experience for the application of adalimumab in Chinese psoriasis patients.
In the final session, Professor Xinghua Gao summarized the three-aspect interpretation from Professor Li: the introduction to biosimilars, the application of adalimumab in psoriasis, and the evidence-based interpretation of Han Da Yuan® in China for psoriasis; biosimilars are more and more recognized both in China and abroad, and the development of biologics in China is also very rapid; biosimilars allow patients to enjoy high-quality and low-cost treatment. He also pointed out that: with support by National Science and Technology Major Project (Major New Drug Development), it is the first adalimumab biosimilar in China produced in a facility with both China and EU GMP certifications. And he expressed his hope that Wanbang Pharma, as a wholly-owned subsidiary of Fosun Pharma, will provide high-quality and low-cost products and services in the future to benefit more patients.