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Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration
"The submission of ABP 980 for
"Today's submission is our second U.S. biosimilar submission in less than a year as part of our collaboration with
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.
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.
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Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen's supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.
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