On December 2, 2016 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab) (Press release, Amgen, DEC 2, 2016, View Source [SID1234516874]). The companies believe this submission is the first bevacizumab biosimilar application submitted to the EMA. Schedule your 30 min Free 1stOncology Demo! "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."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
About ABP 215
ABP 215 is being developed as a biosimilar to bevacizumab, which 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.