Official answer: There are currently 64 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar...
An up-to-date resource showing all biosimilars approved in the US as well as biosimilar applications filed with FDA, based on public records. Updated frequently, the number of biosimilars approved for marketing has risen markedly, while the biosimilars l
Biosimilars are, by definition, very similar to medications that have been approved by FDA. Often, the original drug approved is called the reference product. These similar drugs have the same clinical efficacy and safety as their reference drugs already approved. Some biosimilars are made from ...
The FDA approved aflibercept-jbvf (Yesafili; Biocon Biologics) and aflibercept-yszy (Opuviz; Biogen, Samsung Bioepis), the first interchangeable biosimilars to aflibercept (Eylea; Regeneron). Aflibercept inhibits vascular endothelia growth factor, preventing abnormal blood vessel growth in the eye, th...
According to the Food and Drug Administration (FDA) biosimilars dashboard, the agency has approved 50 biosimilar products since 2015. And more are coming; nearly 100 products are enrolled in the agency’s fee-based product development program for biosimilars, which was created to help streamline ...
AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,… Read More Alvotech and Bioventure Announce Approval of ...
Otulfi (Fresenius Kabi/Formycon) was approved by the FDA in October 2024. Several other potential biosimilar candidates are under development, including BAT2206 (Bio-Thera), DMB-3115 (Dong-A ST), QX001S (Qyuns Therapeutic), BFI-751 (BioFactura), NeuLara (Neuclone), ONS3040 (Onco...
BySkylar Jeremias January 22nd 2025 In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition. ...
In May 2018, the FDA also approved a biosimilar to treat anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV. The process of developing a biosimilar and getting it approved is different ...
FDA-approved biosimilars FDA Biosimilar Curriculum Contact us Your source for biosimilars As one of the largest healthcare distributors in the United States (U.S.), Cardinal Health has broad access to commercially available biosimilars, as well as a deep understanding of the clinical and economic ...