publication date: Nov. 18, 2016

Drugs and Targets Amgen, Allergan submit application for biosimilar bevacizumab

AMGEN and ALLERGAN plc. have submitted a Biologics License Application to FDA for ABP 215, a biosimilar candidate to Avastin (bevacizumab). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies said they believe this submission is the first bevacizumab biosimilar application submitted to FDA.

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

It will be 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 BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer. The phase 3 study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.

Avastin is sponsored by Genentech, a unit of Roche.

 

PKC412 (midostaurin) was … Continue reading Amgen, Allergan submit application for biosimilar bevacizumab

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