資料來源：https://www.prnewswire.com/news-releases/amgen-and-allergan-submit-biosimilar-biologics-license-application-for-abp-980-to-us-food-and-drug-administration-300496238.html

Amgen and Allergan plc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

"Today's submission is our second U.S. biosimilar submission in less than a year as part of our collaboration with Amgen," said David Nicholson, chief R&D officer at Allergan. "We're proud of the progress we've made so far and look forward to continuing our work to bring more biosimilars to market."

ABP 980 is a biosimilar candidate to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2. Trastuzumab is approved for the treatment of HER2-positive adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer in the U.S.

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 female patients with HER2-positive early breast cancer.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the FDA.

About ABP 980

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody approved in many regions for the treatment of HER2-overexpressing early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab. Amgen and Allergan also submitted a Marketing Authorization Application to the European Medicines Agency for ABP 980 earlier this year.

About the Amgen and Allergan Collaboration

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.