FDA approves Pfizer’s oncology mAb biosimilar Zirabev

02-Jul-2019 - Last updated on 21-Aug-2019 at 19:38 GMT

(Image: Getty/AndreyPopov)

Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.

The US Food and Drug Administration (FDA) approved Pfizer’s biosimilar Zirabev (bevacizumab), which will enter the US market as a rival to the originator treatment, Roche’s Avastin.

Zirabev is a monoclonal antibody (mAb) that works to inhibit the formation of new blood cells by recognizing and binding to vascular endothelial growth factor protein.

A spokesperson for Pfizer told us that while normal cells make this growth factor protein, increased levels of it are made by some cancer cells and blocking it may prevent the growth of new blood vessels that feed tumors.

“Unlike traditional chemotherapy that attacks cancer cells, bevacizumab blocks the blood supply that feeds the tumor, which can stop the tumor from growing,” the spokesperson added.

Approval of the drug comes after the results of Pfizer’s clinical comparative study showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Andy Schmeltz, global president of Pfizer Oncology, said in a statement that biosimilars like Zirabev can increase access to therapies and drive market competition that may ultimately lower costs of such treatments.

The biosimilar will be available for the treatment of metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.

In February 2019, Zirabev was approved for use in the European Union.

Avastin is a blockbuster drug for Roche with global sales of $6.5bn (€5.71bn) and multiple biosimilar producers aiming to create versions of the drug. In 2018, Roche stated it was preparing to face biosimilar competition for its soon-to-be- off-patent biologics, such as Avastin and its other drug MabThera (rituximab) – marketed as Rituxan by Biogen in the US.

With the approval of Zirabev, Pfizer now has two FDA approved oncology mAb biosimilars. Pfizer’s Trazimera (trastuzumab-qyyp) was approved in March 2019 for the treatment of HER2 positive breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.