The Biologics License Application (BLA) for ABP 215, is about to go for review according to Amgen, Inc. (NASDAQ:AMGN) and Allergan plc Ordinary Shares (NYSE:AGN). The duo says that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will be evaluating data for the biosimilar candidate to Avastin on July 13, 2017. The evaluation, which will be seeking to ascertain whether or not bevacizumab has reached its primary endpoint, will include results from a Phase 3 study.
Amgen and Allergan share a common belief in biosimilar products
The committee will be reviewing analytical, pharmacokinetic and clinical data from the studies of a biosimilar candidate to bevacizumab. ABP 215 is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb), which binds to vascular endothelial growth factor (VEGF). It has been approved in the U.S., EU and several other regions as a treatment for unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC.
However, both Amgen and Allergan hold onto a similar belief in the development and commercialization of biosimilar products. Hence their collaboration, which is also vital given that each of them, has unique expertise. Executive VP of Research and Development at Amgen Sean E. Harper quotes, “Amgen has a long and proud heritage in oncology, and we are committed to providing physicians and patients a range of high-quality therapeutic options.”
Amgen has a total of 10 biosimilars in its portfolio and one has been approved by the FDA. However, they will both be working on another four oncology biosimilars.
Let’s explore the scenes behind the collaboration
The collaboration dates back to December 2011 when the two agreed to develop and commercialize four oncology antibody biosimilar medicines. Their aim was to demonstrate the need for significant expertise, infrastructure, and reliability in supplying therapies for patients. With more than 35 years of experience in biotechnology, Amgen is well positioned to leverage the creation of high-quality biosimilars.
Amgen’s supportive care treatments have been helping patients take on some of the toughest cancers, of which a majority been resistant to drugs. In the meantime, Amgen’s stock closed at $162.65 witnessing an increase of $0.99 or 0.61% while that of Allergan closed at $229.41 witnessing an increase of $1.26 or 0.55%.
