MB02, a bevacizumab biosimilar, has demonstrated analytical similarity to reference bevacizumab on a comprehensive chemistry, manufacturing, and control (CMC) and bioanalytical similarity program. PK similarity has been further confirmed in three bioequivalence studies comparing the pharmacokinetic profiles of MB02 and reference bevacizumab following the administration of a single dose (3 mg/kg IV) in more than 276 healthy male subjects.

The STELLA clinical equivalence study compared both drugs in the first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) patients as the last step in biosimilarity assessment. Results from this study provide reassurance that clinical activity, and hence efficacy, clinical safety and immunogenicity of MB02 and reference bevacizumab are comparable.

The results contribute to the totality of evidence demonstrating similarity of MB02 bevacizumab candidate with the marketed reference product. The incorporation of MB02 into the therapeutic armamentarium of bevacizumab biosimilar drugs would increase the options for cancer patients, whether alone, in combination with standard chemotherapy or with novel immunotherapy.