In this study, therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug was found.

• Participants were 357 patients with no previous treatment for advanced non-squamous non-small-cell lung cancer who were randomized 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin.

• In the BCD-022 and reference bevacizumab groups, the overall response rate was 34.63% and 33.82%, respectively.

• Limits of 95% CI for the difference in overall response rates and for the ratio of overall response rate between the groups were [-9.47%; 11.09%] and [79.6%; 131.73%], respectively.

• For both approaches CI lied within predetermined equivalence margins.

• Similar profile of adverse events was noted between the groups, and no unexpected adverse reactions occurred.

• Anti-drug antibody occurrence rate did not differ statistically significantly between BCD-022 (n=4; 1.96%) and comparator (n=5; 3.65%).

• Low occurrence rate and short life of anti-bevacizumab antibodies were demonstrated by both drug products.

• Pharmacokinetics evaluation after 1 ^st and 6 ^th study drug injection also showed equivalent pharmacokinetics parameters by all outcome measures.