Positive phase I results for Qilu’s bevacizumab copy biological

Biosimilars/Research | Posted 20/03/2020 post-comment0 Post your comment

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].

Clinical Trials 2 V13K29

In the double-blind, single-dose, parallel-group study, 82 healthy male subjects were randomized 1:1 to receive QL1101 (42) or Avastin (40) intravenously at a dose of 3 mg/kg.

The 90% confidence intervals (CIs) of the geometric mean ratios of area under the concentration–time curve (AUC) from time zero to infinity (AUC0-∞), AUC from time zero to the last quantifiable concentration (AUC0-last) and maximum serum concentration (Cmax) of QL1101 and Avastin were (97.8%, 107.0%), (94.5%, 106.9%), and (94.1%, 107.3%), respectively, which were all within the predefined bioequivalence margin of 80%−125.00%.

The incidence of adverse events was 90.5% and 95.0% in the QL1101 and Avastin groups, respectively. Mean serum concentration–time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across the two treatment groups.

Based on these results, the authors concluded that ‘the study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin’. They added that ‘QL1101 (3 mg/kg, intravenous) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar’.

QL1101, is produced by Chinese pharmaceutical company Qilu Pharmaceutical (Qilu). It has also been tested in two phase III trials in non-small cell lung cancer in China (first-line therapy; NCT03169335 and second-line therapy or greater; NCT03195569). According to the authors the results of these phase III studies ‘will be reported in a separate communication that is currently in development’.

In December 2019, QL1101 was approved as Ankada by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer [2].

Qilu has also started a phase III trial for a denosumab copy biological [3].

Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest. However, it should be noted that one of the authors is an employee of Qilu.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Biosimilars of bevacizumab

1. Liu YN, Huang J, Guo C, et al. A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects. Cancer Chemother Pharmacol. 2020;85(3):555-62.
2. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Ankada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Ankada
3. GaBI Online - Generics and Biosimilars Initiative. Qilu starts phase III trial for denosumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/Qilu-starts-phase-III-trial-for-denosumab-copy-biological

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