Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration.
"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," Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement. " 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 and Amgen are collaborating on four oncology biosimilars. ABP 980 is the second of those four to be submitted to the FDA for approval. Similar to trastuzumab, ABP 980 is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2-positive early breast cancer.
"Today's submission is our second U.S. biosimilar submission in less than a year as part of our collaboration with Amgen," David Nicholson, chief R&D officer at Allergan, said. "We're proud of the progress we've made so far and look forward to continuing our work to bring more biosimilars to market."