The FDA has accepted the biologics license application for Mylan’s proposed biosimilar trastuzumab, for filing through the 351(k) pathway. MYL-14010 is designed to treat certain types of human epidermal growth factor receptor 2 (HER2) positive breast cancers.

HER2 promotes cancer cell growth, and trastuzumab is thought to counteract the condition. The FDA has approved the use of trastuzumab for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, as well as HER2-overexpressing breast cancer.

In a clinical trials, the most common adverse effects associated with trastuzumab in combination with chemotherapy in patients were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

"The FDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the United States.,” Mylan President Rajiv Malik, said in a press release. “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.”

The anticipated FDA goal date according to the Biosimilar User Fee Act is September 3, 2017. Mylan submitted its BLA along with Biocon, its partner on biosimilar and insulin products.