Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Outlook Therapeutics Inc. CEO Russell Trenary said positive results from the phase III study called Norse Two represent “the final step we need” to proceed with the BLA in the first quarter of next year for an ophthalmic formulation of the VEGF binder bevacizumab to treat wet age-related macular degeneration (AMD).
BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.
BEIJING – Jinan, China-based Qilu Pharmaceutical Co. Ltd. has won the first approval for a China-developed biosimilar to Avastin (bevacizumab, Roche Holding AG). Its biosimilar QL-1101, to be sold under the trade name Ankada, has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.