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FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 30, 2017

The FDA has extended its decision deadline by 3 months on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon. Under the new timeframe, a final decision is expected on or before December 3, 2017.

In a briefing document used for the July ODAC meeting, FDA staff concluded that data from MYL-HER-1002 showed that MYL-1401O demonstrated a similar PK profile with US- and EU-approved trastuzumab (see table).

Table 

Table


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