China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved for use in combination with FOLFOX or FOLFIRI regimen for the first-line treatment of RAS gene wild-type metastatic colorectal cancer.
First Biosimilar of Erbitux in China
Erbitux was approved for marketing in the United States in 2004 and gained approval in China the following year. Datailai is the first biosimilar version of Erbitux to be approved in China. The NMPA’s approval is based on results from a randomized, double-blind, controlled, multi-center Phase III study. The study compared Datailai in combination with chemotherapy head-to-head against Erbitux combined with chemotherapy in first-line RAS wild-type metastctal colorectal cancer.
Clinical Equivalence Demonstrated
Clinical data showed that the Datailai combination had clinical equivalence in objective response rate (ORR) compared to the Erbitux/chemotherapy combination (71.0% vs 77.5%), with no clinically or statistically significant difference in response duration (mDoR: 10.2 months vs 9.5 months) and progression-free survival (mPFS: 10.9 months vs 10.8 months). Additionally, Datailai was found to be on par with Erbitux in terms of safety, tolerability, and immunogenicity.-Fineline Info & Tech
