Amgen and Allergan submit biosimilar marketing authorization application to European Medicines Agency for ABP 215, a biosimilar candidate to bevacizumab.
Amgen and Allergan plc. announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Genentech, Inc.’s Avastin (bevacizumab). The companies believe this submission is the first bevacizumab biosimilar application submitted to the EMA.
“The submission of ABP 215 to the EMA is an important milestone as Amgen seeks to expand our oncology portfolio,” said Sean E. Harper, M.D., executive vice president of research and development at Amgen. “Amgen is committed to delivering medicines to patients worldwide and ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer.”
“The EMA submission of ABP 215 marks an important step forward in providing a potential therapeutic option for patients diagnosed with cancer. Allergan is committed to globally developing high-quality therapies in critical disease areas,” said David Nicholson, chief research and development officer at Allergan.
ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) 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 3 comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase 3 study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.
Bevacizumab is approved in the U.S., EU 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.
(Source: PR Newswire)