Pfizer's Herceptin Biosimilar Trazimera Gets FDA Approval

Pfizer, Inc. (NYSE:PFE) announced FDA approval of Trazimera, a biosimilar version Roche’s (OTC:RHHBY) breast cancer drug, Herceptin.

Trazimera is approved for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric cancer. We remind investors that in April last year, the FDA had given a complete response letter (CRL) to Pfizer’s biologics license application (BLA) for Herceptin biosimilar. The FDA, back then, had asked for additional technical information though it was not related to safety or clinical data submitted in the application.

The BLA filing was based on a comprehensive data package, which included data from the REFLECTIONS B3271002 study, a comparative safety and efficacy study of Trazimera in combination with paclitaxel versus a combination of Herceptin and paclitaxel in first-line patients with HER2-positive metastatic breast cancer. Data from the study showed that the primary endpoint of objective response rate (ORR) was equivalent for Trazimera and Herceptin.

We remind investors that in January this year, Samsung (KS:005930) Bioepis Co., Ltd and its partner, Merck received FDA approval for their Herceptin biosimilar, Ontruzant. Ontruzant was Samsung Bioepis’ first oncology biosimilar to receive FDA approval. In December last year, Celltrion and Teva Pharmaceutical (NYSE:TEVA) Industries’ biosimilar version of Herceptin, Herzuma gained FDA’s approval

Pfizer’s shares have declined 4.9% this year so far against an increase of 2.1% for the industry.

Trazimera is Pfizer’s first oncology biosimilar to get approved in the United States. At present, in the United States, Pfizer marketsInflectra, its first biosimilar version of J&J/Merck’s Remicade,which was launched inNovember 2016. In Europe and United States, Pfizer also markets biosimilar versions of Amgen’s (NASDAQ:AMGN) drugs, Neupogen and Epogen.

Gradually, Pfizer is venturing into the oncology biosimilars space. Biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (Zirabev) arealsounder review in the United States with FDA decisions on all expected in 2019. With a biosimilar version of AbbVie’s (NYSE:ABBV) Humira also under review in the United States, Pfizer expects potential U.S. approvals for up to four biosimilar products in 2019.

Biosimilar versions of Herceptin and Avastin are already approved in the EU while that of Rituxan is under review in the EU. Meanwhile, Pfizer is evaluating several biosimilar molecules in various stages of development.

Pfizer currently carries a Zacks Rank #4 (Sell).

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