The FDA approved Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.
The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer.
Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab). The biosimilar is also the second product developed by Bio-Thera Solutions, a Guangzhou, China-based pharmaceutical company, to receive FDA approval.
The biosimilar is approved for 7 indications, including:
The approval was based on a data package containing results from nonclinical and clinicals trials to compare the safety and efficacy of Avzivi (BAT1706) and the US- and EU-sourced reference product.
During a randomized double-blind phase 1 trial, the pharmacokinetics, safety, and immunogenicity of BAT1706 were evaluated in healthy volunteers, comparing it with both US and EU Avastin. Following this, a randomized double-blind phase 3 study with 3 arms investigated the efficacy, safety, and immunogenicity of BAT1706 in individuals with advanced non-squamous non-small cell lung cancer, comparing it to Avastin. The combined results from these studies provide compelling evidence that BAT1706 demonstrates efficacy, safety, immunogenicity, and quality similar to the reference product bevacizumab.
"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," said Li Zhang, PhD, leading investigator for global phase 3 study of Avzivi. "The global phase III clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity. The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option. We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."
When it launches, the product will be marketed by Sandoz as part of a September 2021 license and commercialization agreement for BAT1706. Under the terms of the agreement, Bio-Thera is responsible for development and manufacturing of the biosimilar. Sandoz also has the commercialization rights is all countries outside the United States.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.