On April 23, 2018, Pfizer announced that it received a complete response letter (CRL) from FDA in response to the biologics license application (BLA) for the company’s proposed trastuzumab biosimilar, which references Roche’s Herceptin (trastuzumab). Trastuzumab made approximately US$7 million in 2017 sales.
In the CRL, FDA emphasized the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer states it is working with FDA to address the contents of the letter.
The agency also issued CRLs to Celltrion for the BLAs for CT-P10 (rituximab), a proposed biosimilar to Roche’s Rituxan/MabThera (rituximab), and CT-P6 (trastuzumab), a proposed biosimilar to Roche’s Herceptin (trastuzumab) in early April 2018. The CRLs stem from a warning letter that FDA issued to Celltrion on Jan. 26, 2018 after an inspection carried out from May 22 to June 2, 2017 at Celltrion’s drug manufacturing facility in Incheon, South Korea. The letter raised issues related to certain manufacturing process at the facility.