Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for MYL-141O, the proposed biosimilar to trastuzumab.
Trastuzumab (Herceptin; Genentech) is indicated to treat HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel in patients who have not received chemotherapy; as adjuvant treatment in HER2-overexpressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin). It is also indicated to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with cisplatin and capecitabine or 5-fluorouracil, in patients who have not received prior treatment.
The BLA contains detailed analytical similarity, nonclinical, and clinical data, including data from the two pharmacokinetic studies and the HERITAGE confirmatory efficacy and safety trial. The submission allows the opportunity for MYL-141O to be the first biosimilar to trastuzumab to be approved.