After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
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.
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.