FDA Accepts BLA for Trastuzumab Biosimilar

The FDA anticipated goal date for a decision on the biosimilar is September 7, 2017
The FDA anticipated goal date for a decision on the biosimilar is September 7, 2017

Mylan announced that the Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for their biosimilar to trastuzumab, MYL-1401O.

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. 

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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.

For more information visit Mylan.com.

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