Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).
The momentum of China’s biosimilars market is illustrated by 2 major milestones in just the past year. In December 2019, Chinese regulators approved the first domestically developed bevacizumab biosimilar of Avastin. In February 2019, China approved its first-ever biosimilar, Shanghai Henlius biotech’s HLX01, a biosimilar of Roche’s rituximab (Rituxan).
QL 1101 (Ankada), developed by Qilu Pharmaceutical, was approved by the China National Medical Products Administration (NMPA) for patients with metastatic or recurrent non—small cell lung cancer (NSCLC) and metastatic colorectal cancer.
According to a recently published phase 1 study, the pharmacokinetics of QL 1101 were demonstrably similar to those of the reference product.
“Laboratory results, physical examination findings, vital signs, and electrocardiogram values were unremarkable, with no safety issues identified and with no clinically meaningful differences among the 2 treatment groups,” investigators said.
In the United States, Avastin is indicated for the treatment of metastatic colorectal cancer, glioblastoma, metastatic breast cancer, NSCLC, and metastatic renal cell carcinoma. Two bevacizumab biosimilars are currently marketed here: Amgen/Allergan’s Mvasi and Pfizer’s Zirabev. FDA decisions are expected on 2 more: Samsung Bioepis’ SB8 and Mylan/Biocon’s MYL-14020.
Bevacizumab is a recombinant humanized monoclonal antibody (mAb) that works as an inhibitor of vascular endothelial growth factor (VEGF), which is known to induce angiogenesis (formation of new blood vessels) and tumor growth.
China’s biosimilar market is expected to grow 10.4% in 2020 and the country’s push to grow its biosimilars market is likely to put high pressure on manufacturers of originals, especially Roche. Shanghai Henlius Biotech has biosimilar versions of trastuzumab (Herceptin) and bevacizumab in phase 3 trials, according to IHS Markit.
Recombinant mAbs play an important role in cancer treatment and there is a need for lower cost drugs in China. “The market for biosimilars still is not established and their ability to penetrate clinical practice still is not confirmed, so more and more countries are taking steps on paving the way for biosimilars,” authors of the phase 1 study noted.
In the study, healthy patients ages 18 to 40 (n = 82) were randomized to QL 1101 and Avastin. Dosages for each drug were lower than what would be given to a patient with cancer in order to reduce any potential damage to healthy subjects. The incidence of adverse events was 90.5% and 95.0% in the QL 1101 and Avastin groups, respectively. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable between the 2 cohorts. Investigators concluded QL 1101 demonstrated pharmacokinetic equivalence to Avastin, as well as safety and tolerability.
In general, there were no statistically significant differences between the 2 groups with respect to adverse events, adverse reactions, serious adverse events, and important adverse events, investigators said.
Other clinical studies of QL 1101 also have demonstrated equivalence to reference bevacizumab.
Liu YN, Huang J, Guo C, et al. Randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects. Cancer Chemother Pharmacol. 2020; 85(3):555-562. doi: 10.1007/s00280-019-04014-x.