FDA Committee in Favor of Herceptin Biosimilar Approval

The panel voted 16–0 to support the eligible indications of Herceptin for the biosimilar trastuzumab
The panel voted 16–0 to support the eligible indications of Herceptin for the biosimilar trastuzumab

Mylan and Biocon announced that the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted to recommend approval of biosimilar trastuzumab, the first proposed biosimilar to Genentech's Herceptin.

The panel reviewed data from non-clinical and clinical studies as well as analyses showing that the proposed biosimilar trastuzumab was highly similar to Herceptin. They voted 16–0 to support the eligible indications of Herceptin for the biosimilar trastuzumab and concluded that no clinically meaningful differences were seen between the biosimilar and the reference product regarding safety, purity, and potency. 

Herceptin, a human epidermal growth factor receptor (HER2) inhibitor, is currently approved 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. It is also indicated 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). 

Herceptin is also approved 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 FDA is not bound to follow the advice of the ODAC in deciding the approval of a product but will take the recommendation into consideration. 

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