Amgen, Allergan Seek Approval for Avastin Biosimilar
Amgen and Allergan have submitted a biologics license application to the US Food and Drug Administration (FDA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab), Roche’s anti-cancer biologic. ABP 215 is the most advanced of the four oncology biosimilar medicines on which Amgen and Allergan are collaborating.
Avastin is Roches’ top-selling drug with 2015 sales of CHF 6.68 billion ($6.56) billion. Avastin is indicated in the US for treating metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, and platinum-restistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Bevacizumab is approved in the US, European Union, and other regions for treating patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic carcinoma of the colon or rectum, metastatic renal cell carcinoma, and other region-specific indications.
Amgen has a total of nine biosimilars in its portfolio, one of which, Amjevita (adalimumab-atto), was approved by the FDA in September 2016. Amjevita is a biosimilar of Humira (adalimumab), AbbVie’s anti tumor necrosis factor (TNF) monoclonal antibody that is indicated in the US for treating rheumatoid arthrititis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Chrohn’s disease, and ulcerative colitis. Eight of the nine biosimilars that Amgen has in its portfolio are in ongoing development. Allergan is also independently developing biosimilars.
The companies formed their collaboration in December 2011 to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Under the agreement, Amgen will assume primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.