Pfizer secures FDA approval for oncology biosimilar Zirabev; stock gains

A day after appointing former FDA chief Scott Gottlieb to its board of directors, pharma giant Pfizer (PFE) said it received FDA approval for its new cancer drug Zirabev. The company’s stock was up 1% in the early trading Friday.

Zirabev, a biosimilar to popular cancer drug Avastin, is indicated for the treatment of certain types of metastatic colorectal cancer, non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and metastatic cervical cancer. Earlier, an advanced stage clinical comparative study established the biosimilarity of Zirabev to Avastin, confirming that there were no clinically meaningful differences between the two when administered in patients.

Zirabev, a biosimilar to Avastin, is indicated for the treatment of certain types of cancers

“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,” said Andy Schmeltz, Global President of Pfizer Oncology.

The success of Zirabev is expected to give an impetus to the company’s aggressive expansion of the biosimilar portfolio and pipeline, which is an emerging healthcare segment that offers patients a sustainable new option to deal with serious health issues. The company has been at the forefront of biosimiar research in the US.

In March, Pfizer secured the regulatory nod for Trazimera, an oncology monoclonal antibody biosimilar, a month after Zirabev was approved for sale in the European Union for the treatment of patients suffering from as many as five different types of cancer.

Once commercially launched, the new product is expected to contribute significantly to revenue growth in the coming years, considering the growing demand for oncology therapies across the globe. It works by preventing the formation of new blood cells by specifically recognizing and binding to vascular endothelial growth factor protein.

Also read: Pfizer Q1 profit tops expectations

Recently, Pfizer appointed Scott Gottlieb, a former commissioner of the FDA who is currently a resident fellow at the American Enterprise Institute, to its board of directors. Earlier this month, the company acquired Array Biopharma (ARRY) for $10.64 billion as part of expanding its oncology portfolio.

After slipping to a nine-month low in April, Pfizer shares have maintained a steady uptrend. Currently, they are trading at the levels seen at the beginning of the year. The stock has gained 20% in the past twelve months.

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