On December 14th, the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) announced that it has accepted the market application for Zhejiang Huahai Pharmaceutical Co., Ltd’s (SHA: 600521) adalimumab biosimilar injection. Adalimumab is a fully human anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody.
The Role of TNF-α in Autoimmune Diseases
TNF-α is one of the primary cytokines that induce inflammation and other immune responses, playing a pivotal role in the pathogenesis of various autoimmune diseases. Conditions such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis have been proven to be closely related to TNF-α.
Adalimumab’s Mechanism of Action and Global Recommendations
Adalimumab, a fully human anti-TNF-α monoclonal antibody originally developed by AbbVie (NYSE: ABBV), specifically binds to TNF-α, blocking its interaction with TNF receptors p55 and p75. This effectively inhibits the inflammatory actions mediated by TNF-α and provides effective and sustained control over various autoimmune diseases. Due to its established efficacy and safety profile in the field of autoimmune diseases, adalimumab has been recommended in multiple global authoritative autoimmune disease treatment guidelines.
Huahai’s Development and Clinical Progress of the Biosimilar
As introduced in previous press releases from Huahai Pharmaceutical, the company had previously introduced the adalimumab biosimilar product from US based Oncobiology. According to the official website of the China Drug Clinical Trial Registration and Information Public Platform, Huahai’s subsidiary, Huaota Biopharmaceutical, has completed a Phase III clinical study. The study aimed to evaluate the efficacy and safety of the recombinant fully human anti-tumor necrosis factor-alpha monoclonal antibody injection (HOT-3010) compared to the original adalimumab product in treating adult patients with moderate to severe chronic plaque psoriasis.-Fineline Info & Tech
