Bevacizumab Biosimilar Update

gloved hand withdraws drug solution with syringe

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab).  Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer.

The Korea Herald is reporting that the Korean Ministry of Food and Drug Safety has approved Celltrion to start Phase 1 trials for CT-P16, its proposed biosimilar to Avastin.  The phase 1 trials will be done locally, and will compare efficacy of CT-P16 to Avastin.  According to the article, Celltrion is aiming to file its Avastin biosimilar with the Korean regulatory authorities for approval next year.

Pfizer also announced yesterday positive top-line results from a comparative, confirmatory safety and efficacy study of its own proposed bevacizumab biosimilar, PF-06439535, versus Avastin.  The REFLECTIONS B7391003 trial is a comparative, randomized, double blind, clinical trial [N=719] evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of PF-06439535 in combination with carboplatin/paclitaxel versus Avastin in combination with carboplatin/paclitaxel for the first line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC).  Pfizer reported that the trial demonstrated equivalence in the primary endpoint of objective response rate of PF-06439535 versus Avastin, taken in combination with carboplatin/paclitaxel, for the first line treatment of patients with advanced NSCLC.