Posted from: Monday, April 08, 2019 - 04:01 PM - Present

Trazimera Approved as Biosimilar for Herceptin

March 12, 2019 – The U.S. FDA has approved Trazimera™ (trastuzumab-qyyp), manufactured by Pfizer, as a biosimilar to Genentech’s Herceptin® (trastuzumab). The product is the fourth Herceptin biosimilar to receive approval in the United States, and is indicated to treat HER2-overexpressing breast cancer or gastroesophageal junction adenocarcinoma.

An estimated 15-30% of breast cancer cases and 10-30% of gastric cancers are HER2 positive. Trastuzumab products like Trazimera work by attaching to the HER2 protein expressed by these cancer cells and inhibiting their ability to divide and grow. 

As a biosimilar, Trazimera is not automatically interchangeable with Herceptin, but may offer patients an alternative. Recommended dosing is dependent on individual patient factors. A black box warning cautions that trastuzumab products can cause cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

Pfizer has not yet announced launch or pricing plans.

Last Updated Friday, August 23, 2019 - 04:49 PM.