EC Approves Pfizer’s Biosimilar to Roche’s Herceptin

Aug 07, 2018
By Pharmaceutical Technology Editors

On July 31, 2018, the European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, for treating human epidermal growth factor (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma cancer. Herceptin, a top-selling product for Roche, made CHF 7.01 billion (US$7.04 billion) in 2017 sales.

Pfizer states that Trazimerais the company’s fourth biosimilar to receive European approval. Pfizer’s biosimilars pipeline consists of nine distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development. Pfizer acquired Hospira in September 2015 for $17 billion.

Pfizer’s trastuzumab to date is not approved by FDA. In April 2018, Pfizer received a complete response letter (CRL) from FDA in response to the biologics license application for Trazimera in which 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. 

In May 2018, FDA granted Hospira approval for Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen/Procrit (epoetin alfa), to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in HIV patients. Amgen’s Epogen/Procrit made $1.1 million in 2017 sales.

“The approval of Trazimera, Pfizer’s first oncology biosimilar, is another significant step in our quest to introduce more treatment options for patients in Europe,” said Richard Blackburn, global president, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars, in a company press release. “Pfizer is investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines.”

Source: Pfizer

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