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Drugs & Targets

Pfizer gets Complete Response Letter for trastuzumab biosimilar

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Pfizer Inc. announced it has received a Complete Response Letter from FDA in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, 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 company said. Pfizer said it’s working closely with FDA to address the contents of the letter.

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