FDA Accepts BLA for Trastuzumab Biosimilar
The submission is in collaboration with Biocon, and is filed through the 351(k) pathway with an anticipated FDA goal date set for September 2, 2017.
“We believe that our comprehensive package of analytical similarity, non-clinical and clinical data submitted with the BLA will demonstrate similarity of the proposed biosimilar trastuzumab to the reference product,” said Mylan's president, Rajiv Malik.
Trastuzumab, marketed under the brand name Herceptin (Genentech) is a human epidermal growth factor receptor (HER2) inhibitor indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
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