Amgen and Allergan plc. announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (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 believe this submission is the first bevacizumab biosimilar application submitted to the FDA.
"ABP 215 is one of four oncology biosimilars in our pipeline, and today's BLA submission 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. "ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer, continuing Amgen's mission of providing patients with vital medicines."
"Allergan is committed to developing safe and effective therapies in certain critical disease areas," said David Nicholson, chief R&D officer at Allergan. "The filing of ABP 215 is an important step forward in advancing a potential treatment option for patients with disorders susceptible to VEGF inhibition."
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 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 (NSCLC). The phase 3 study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in its portfolio, one which has been approved by the FDA (adalimumab-atto) and eight which are in ongoing development. Allergan is also independently developing biosimilars.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Allergan plc, headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.