Amgen & Allergan Submit Biosimilar Marketing Authorization Application

Amgen and Allergan plc. recently announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to 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, MD, 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,” added 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 III comparative efficacy, safety, and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase III study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.

ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in the US, 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.

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. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.

Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide. For more information, visit www.amgenbiosimilars.com.

Allergan plc, headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing, manufacturing, and commercializing branded pharmaceuticals, devices, and biologic products for patients around the world. For more information, visit www.Allergan.com.