Home Avastin FDA Approves Pfizer’s Biosimilar, Zirabev, to Roche’s Avastin

FDA Approves Pfizer’s Biosimilar, Zirabev, to Roche’s Avastin

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Oncology

The FDA has approved bevacizumab-bvxr (Zirabev, Pfizer), a biosimilar to bevacizumab (Avastin, Genentech/Roche), for the treatment of five types of cancer. These cancers include metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

The regulatory agency approved the biosimilar based on the submission package the agency agreed evidenced bio similarity of bevacizumab-bzr to the reference product.  The reference product, Avastin, from Roche, generates nearly $7 billion per year in sales.

REFLECTIONS Trial

The regulatory submissions package included reference to the results from the REFLECTIONS B7391003 clinical comparative study, which revealed clinical equivalence. The sponsor found no clinically meaningful differences between bevacizumab-bvzr and the reference product in patients with advanced nonsquamous NSCLC. The sponsor presented the results at ASCO 2019.

The biosimilar has been evaluated in over 400 patients to date.

Adverse Reactions

Adverse reactions reported at greater than 10% included epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pin and exfoliative dermatitis.

The discontinuation rate across all bevacizumab, due to adverse reactions, was in the range of 8% to 22% of patients.

Gastrointestinal perforation issues, from serious to fatal, occurred at a higher rate in patients receiving bevacizumab products compared to those receiving chemotherapy.

Bevacizumab must be withheld for at least 28 days prior to elective surgery due to higher incidents of wound healing and surgical complications. This is due to impact of bevacizumab.

Those receiving bevacizumab experienced up to fivefold more frequently the following: severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, central nervous system hemorrhage, epistaxis and vaginal bleeding.  Moreover, grade 3 or higher hemorrhagic events occur among patients receiving bevacizumab ranging from 0.4% to 7%.  Health providers should not administer bevacizumab-bvzr to patients with serious hemorrhage or a recent history of hemoptysis. It should be discontinued to patients who develop grade 3 to 4 hemorrhage.

The bevacizumab-treated arm versus the chemotherapy arm revealed that additional serious and sometimes fatal adverse events increase in the bevacizumab treated arm including:

  • arterial thromboembolic events
  • renal injury and proteinuria
  • nephrotic syndrome
  • venous thromboembolism
  • hypertension
  • posterior reversible encephalopathy syndrome
  • congestive heart failure
  • infusion-related reactions with the first dose of bevacizumab

The Biosimilar

This represents Pfizer’s sixth biosimilar approval for Pfizer. Bevacizumab-bvzr is a monoclonal antibody biosimilar of the reference product, bevacizumab, which works by inhibiting angiogenesis by specifically recognizing and binding to vascular endothelial growth factor protein.

Lead Research/Investigator

Dr. Niels Reinmuth of the Department of Thoracic Oncology, Asklepios Lung Clinic, Munich-Gauting, Germany, reported “Zirabev represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product.”  Dr. Reinmuth continued “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

The Reference Product: Avastin

Avastin is used for a number of types of cancers and a specific eye disease. It was approved for medical use in the United States in 2004. It is on the World Health Organization’s List of Essential Medicines.  The wholesale cost in development is about $638.54 per vial.  It is reported that the cost for intravenous solution (25 mg/ml) is around $841 for a supply of 4 milliliters.  In 2015, Avastin pricing ranged from the following:

  • Lung Cancer:  range from $83,951 to $109,922 per year/per patient
  • Kidney Cancer: range from $114,478 to $149,893
  • Brain Cancer: range from $114,478 to $149,893

Roche (Genentech) generates nearly $7 billion in revenue.  It now may face more competition.

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