Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars.
China-based Innovent Biologics announced last week that IBI305, a potential biosimilar to bevacizumab, met pre-defined primary endpoints in two clinical trials against branded bevacizumab. One trial was a phase III clinical trial that compared objective response rates in 450 patients with advanced non-squamous non-small cell lung cancer. The other trial was a single-dose clinical trial in 100 healthy subjects that compared the pharmacokinetic profile of the two agents.
Bevacizumab and IBI305 are monoclonal antibodies that inhibit the growth of tumors by preventing the formation of new blood vessels and blocking blood supply to tumor tissues. This treatment method is commonly used to treat a number of types of cancers, including non-small cell lung cancer. There are currently no approved bevacizumab biosimilars in China, where lung cancer is the most commonly occurring form of cancer and the mortality of malignant tumors is high.
A group of researchers from Caisse Nationale de l’Assurance Maladie have studied a French nationwide database to compare the safety and effectiveness of the biosimilar CT-P13 against branded infliximab for treating Crohn’s disease. The researchers observed no difference in safety outcomes and concluded that CT-P13 had equivalent efficacy to infliximab.
Like bevacizumab, infliximab and CT-P13 are anti-tumor necrosis factor monoclonal antibodies. The most common uses of infliximab are to treat Crohn’s disease, rheumatoid arthritis, and chronic severe plaque psoriasis. In the United States, Amgen submitted an aBLA to FDA for a different infliximab biosimilar, ABP 710, earlier this week.