Tot Biopharm receives China regulatory approval for a bevacizumab biosimilar and Fujifilm moves forward with plans for a Suzhou Innovation and Collaboration Center.
An industrialized center northwest of Shanghai, China, was the source of a few items of biosimilars news this week.
Suzhou, China-based Tot Biopharm said it has been granted regulatory approval for a bevacizumab biosimilar (Pusintin) by China’s National Medical Products Administration.
Pusintin (TAB008; injectable) is now approved for the treatment of patients with advanced metastatic or recurrent nonsquamous non–small cell lung cancer and metastatic colorectal cancer.
Bevacizumab reduces tumor-supporting blood vessels by targeting vascular endothelial growth factor. Tot Pharma cited pharmaceutical studies and nonclinical and clinical studies demonstrating that Pusintin is equivalent to the reference product, Avastin.
In China, bevacizumab is also approved for treatment of glioblastoma multiforme, hepatocellular carcinoma, ovarian cancer, and cervical cancer. Tot Pharma has commercial-scale manufacturing operations in Suzhou Industrial Park.
Fujifilm Innovation Center
With the growth of biosimilar markets and the demand for more affordable drugs, the market for cell culture development services is growing in China. Biosimilars are made from living organisms, and cell cultures are necessary for development of these therapeutics.
Fujifilm Irvine Scientific, of Santa Ana, California, said it will establish an Innovation and Collaboration Center in Suzhou New District where employees can design upstream cell culture processes for customers’ biomanufacturing needs.
“In the past decade, the world has seen rapid growth in China’s biopharmaceutical, vaccine, cell and gene therapy markets. The speed of approval of biosimilar drugs and investment by the government to make more affordable drugs available to its people is accelerating that growth,” the company said in a statement. Fujifilm said the market for cell culture media is anticipated to grow at an annual rate of 20%.
“The Innovation and Collaboration Center will incorporate advanced cell culture automation and analysis into process and media development to enable highly accurate evaluation and identification of optimal upstream cell culture processes,” Fujifilm said.