EC Approves Pfizer’s Biosimilar to Roche’s Herceptin
The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.
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
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
