The submission includes analytical, pharmacokinetic and clinical data, and pharmacology and toxicology data.
Amgen said that both companies are collaborating on four oncology biosimilar medicines, including ABP 980. The ABP 980 is the second to be submitted for FDA approval.
ABP 980 is a biosimilar candidate to trastuzumab, which is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2.
Trastuzumab has been approved for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer in the US. The phase 3 study of comparative efficacy, safety and immunogenicity was conducted in adult female patients with HER2-positive early breast cancer.
Amgen and Allergan are jointly working to develop and commercialize four oncology biosimilars. Of the 10 biosimilars in Amgen portfolio, one has been approved by the FDA.
Amgen executive vice-president of research and development Sean Harper said: “The submission of ABP 980 for FDA review is an exciting milestone and speaks to our joint commitment with Allergan to deliver quality oncology biosimilars to patients. Approval of ABP 980 would provide more patients access to a high-quality therapy with a proven safety and efficacy profile. We look forward to further discussions with the FDA."
Allergan chief R&D officer David Nicholson said: “Today’s submission is our second US biosimilar submission in less than a year as part of our collaboration with Amgen. We’re proud of the progress we’ve made so far and look forward to continuing our work to bring more biosimilars to market."