First oncology mAb biosimilar from Pfizer approved by FDA

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Dr_Microbe)
(Image: Getty/Dr_Microbe)

Related tags Monoclonal antibodies Pfizer Fda Herceptin Breast cancer HER2

US FDA approves Pfizer’s Trazimera, a biosimilar to Roche’s blockbuster product, Herceptin, for the treatment of HER2 positive breast cancer.

Trazimera (trastuzumab-gyyp) was approved by the US Food and Drug Administration (FDA) for the treatment of HER2 positive breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The newly approved drug from Pfizer is a biosimilar to Genentech's Herceptin (trastuzumab).

Approval for the biosimilar came after a review of a data package of Trazimera that demonstrated a high degree of similarity between it and Herceptin, the originator product; this Included results from a clinical comparative study that showed clinical equivalence, and no clinically meaningful differences between Trazimeria and the originator product.

In July 2018, Trazimera was approved for use in Europe under the same indication.

A spokesperson for Pfizer told us that it believes in the ability of biosimilars to improve access to oncology treatments.

“Biosimilars like Trazimera have the potential to strengthen access to potentially life-changing therapies and can help address the evolving needs of healthcare systems, patients, physicians and payers, particularly as they relate to potentially more affordable cancer treatment options for patients,”​ the spokesperson added.

The approved drug will be Pfizer’s first oncology monoclonal antibody (mAb) biosimilar, and its fifth biosimilar​ to be approved by the FDA. Previously, Pfizer’s Retacrit​ (epoetin alfa-epbx), a biosimilar to J&J’s Procrit and Amgen’s Epogen, was listed 57% less than Procrit and 33.5% less than Epogen in the US market. 

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