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FDA Issues Complete Response Letter for Trastuzumab Biosimilar

Jason M. Broderick @jasoncology
Published: Monday, Apr 23, 2018

Citing the need for additional technical information, the FDA has issued a complete response letter to Pfizer regarding a biologics license application (BLA) for the trastuzumab (Herceptin) biosimilar PF-05280014. 

A BLA for another biosimilar trastuzumab candidate, SB3, was accepted for review by the FDA in December 2017, according to Samsung Bioepis, which is codeveloping the agent with Merck (MSD).
Pfizer presents positive pivotal data for PF-05280014, an investigational biosimilar to Herceptin (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress. Pfizer. Posted September 10, 2017. Access April 23, 2018. https://bit.ly/2HoMj8u.

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