Under the study, Amgen and Allergan evaluated the efficacy and safety of ABP 215 compared with Genentech’s Avastin (bevacizumab) in patients with advanced non-small cell lung cancer.
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In phase 3 trials, Amgen and Allergan’s biosimilar ABP 215 proved that it works similarly to Avastin, both in terms of outcomes and reported adverse events. There were 642 patients enrolled and randomized (1:1) to receive ABP 215 (n = 328) or bevacizumab (n = 314) at a dose of 15 mg/kg administered as an intravenous infusion every three weeks for up to six cycles.
Avastin is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor preventing the growth of new blood vessels necessary for the maintenance and development of solid tumours. ABP 215 met its primary endpoint of clinical equivalence by shrinking tumors at a rate comparable with Roche’s drug, the companies said, and the copycat treatment came through with a matching safety profile. ABP 215 successfully achieved its primary endpoint of demonstrating clinical equivalence compared to Avastin.
We note that Avastin is approved in specific combinations in the USA, European Union and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.
The latest Phase III success marks a clinical victory for Amgen and Allergan’s biosimilar partnership, which began in 2011 and aims to develop four knockoffs of top-selling cancer treatments.
Developing biosimilars is something of a defensive move for Amgen, as its legacy Neupogen/Neulasta franchise was among the first targets for biosimilar developers.
When Zarxio was approved in March, Amgen made it known that it too had biosimilar aspirations, and now it seems that at least one of its drug is getting closer to approval.
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“ABP 215 holds the potential to advance access to treatment options for oncology patients”, Amgen executive VP of research and development Sean Harper said in a statement. Response was determined by independent review based on RECIST criteria. Novartis is also working on an Avastin biosimilar, as are Pfizer (NYSE:PFE) and Boehringer Ingelheim, among others.
