US Ophthalmology Association Warns Against Untested Avastin Alternatives
Discourages Using Pfizer’s Zirabev and Amgen’s Mvasi Biosimilars
The American Academy of Ophthalmology has criticized healthcare insurers for pushing bevacizumab biosimilar alternatives to Avastin, like Pfizer’s Zirabev and Amgen’s Mvasi, that have not been subjected to clinical trials in eye disease or testing for retinal toxicity.
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Outlook Therapeutics has confirmed the re-submission of its proposed ophthalmic bevacizumab with the US Food and Drug Administration, after the agency requested further information.
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection-related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with multiple products seeing action delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.