Pfizer Receives Complete Response Letter from FDA for Trastuzumab aBLA

Today, Pfizer announced that it received a Complete Response Letter (CRL) from the FDA in response to Pfizer’s application for its proposed biosimilar of Herceptin® (trastuzumab).  According to Pfizer’s press release, the CRL “highlighted the need for additional technical information,” but the “requested information does not relate to safety or clinical data submitted in the application.”  Pfizer states that it is “working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the U.S.”

As previously reported, Pfizer is currently engaged in patent litigation under the BPCIA against Genentech regarding its aBLA for this biosimilar candidate.  Genentech originally asserted 40 patents in its complaint, but last month stipulated to dismiss half of those patents and filed an amended complaint alleging infringement of the remaining 20 patents.  Pfizer answered the amended complaint on April 11, 2018.

Stay tuned to Big Molecule Watch for further developments.