Pfizer Inc. (NYSE:PFE) announced on 4/23/18 that it received a Complete Response Letter (CRL) from the FDA in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application.
The FDA approved another biosimilar for Trastuzumab (Herceptin) in December of 2017. The product, was co-developed by Mylan and Biocon.
Roche filed a lawsuit against Pfizer in November of 2017 to prevent Pfizer from developing a Trastuzumab biosimilar.
