Synermore’s anti-rheumatoid arthritis biosimilar SYN060 approved by the Australian TGA for clinical trial
Synermore’s anti-rheumatoid arthritis biosimilar SYN060 has approved by the Australian Therapeutic Goods Administration ( TGA) for the clinical phase I trial study. The trial will target healthy volunteers to evaluate SYN060’s similarities of the pharmacokinetics and safety with Humira® (Adalimumab). The trial will be beginning in September 2017 with a full speed.
Founded in December 2013, Synermore Biologics Co. Ltd. has established a large number of the state-of-the-art technologies and platforms necessary for the development and production of therapeutic monoclonal antibodies, focusing on innovative biologics and high commercial potential biosimilars. The company is committed to providing effective medicines for the unmet medical need therefore contributing to human health and the economic development of Great China.
The current treatment of rheumatoid arthritis and related diseases, therapies fall into two categories: First class is non-steroidal anti-inflammatory painkillers (NSAIDs) or steroids, the goal is to use the lowest dose to control the symptoms in the short time. Another is to change disease progress to improve or control symptoms, which includes administering traditional oral pills (DMARDs) or biological agents. Analgesics (Pain killers or steroids) can control pain, but cannot prevent rheumatoid arthritis from deteriorating! The biopharmaceutical Humira® (Adalimumab) has been successfully developed.
SYN060 has the same mechanism as Humira® and it blocks the TNF receptor activation by specifically binding to human tumor necrosis factor-a(TNF-a), thus regulating the inflammatory response caused by autoimmunity. TNF-a is a natural cytokine associated with normal inflammation and immune responses. It is found its higher concentration in joint fluids of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It plays an important role in pathological inflammation and joint destruction, which are prominent features of these diseases.
Synermore has obtained the key technology for the development of Humira® biosimilar drug and plans to manufacture and sell it in China in the future.
In reference to Humira® sales in 2016, the global market reaches more than 16 billion in US dollars. Therefore, when Synermore successfully completes the SYN060 clinical trials, it is expected to create considerable revenue for the company through potential collaboration with business partners.
Biologics Humira® has been approved in Europe and the United States for the following diseases: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic psoriasis and other autoimmune diseases.