Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche’s Avastin (bevacizumab).
Pfizer said that Zirabev has been approved to treat five types of cancer, including metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma; metastatic renal cell carcinoma (RCC) and persistent, recurrent or metastatic cervical cancer.
The approval was based on assessment of a comprehensive data package, which showed biosimilarity of Zirabev to the reference product.
The data package is comprised of results from the Reflections B7391003 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between ZIRABEV and the reference product in patients with advanced non-squamous NSCLC, said the US pharma giant.
In February this year, the company also received approval from the European Union (EU) for Zirabev to treat of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix.
In March this year, Pfizer also secured FDA approval for another oncology monoclonal antibody (mAb) biosimilar Trazimera (trastuzumab-qyyp).
Zirabev, which is a mAb biosimilar of the reference product Avastin, works by restricting the formation of new blood cells (angiogenesis) by specifically recognising and binding to vascular endothelial growth factor (VEGF) protein.
Zirabev has been assessed in around 400 patients under the Reflections clinical trial programme.
Pfizer oncology global president Andy Schmeltz said: “Biosimilars like ZIRABEV can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer.
“We are proud to add ZIRABEV to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”
Zirabev, in combination with intravenous fluorouracil-based chemotherapy, is approved for the first or second-line treatment of patients with metastatic colorectal cancer (mCRC).
Zirabev, in combination with with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is approved as a second-line treatment for patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.