AMGEN and Allergan plc submitted a Marketing Authorization Application to the European Medicines Agency for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
The companies said they this submission is the first bevacizumab biosimilar application submitted to the EMA.
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.
The MAA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The phase III comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer. The phase III study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply
Warning: This is not a public health recommendation. Do not implement.