Your US review and approval news in brief includes events both good and bad for Pfizer Inc. this week. FDA issued a complete response letter to Pfizer for its biosimilar of Genentech Inc.'s Herceptin (trastuzumab) just weeks after Teva and Celltrion announced they were hit with the agency roadblock for a copy of the HER2/neu receptor antagonist.
The good news for Pfizer was that the drugmaker scooped up breakthrough therapy status for its