
Pfizer Receives CRL for Biosimilar to Roche’s Herceptin
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
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). Roche's Herceptin made approximately CHF 7.01 billion (approximately US$7 billion) in
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
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