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Bookmark or Share- What biosimilars have been approved in the United States? - Drugs.comAccording the to FDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from an existing FDA-approved reference product. Biological products are a diverse category of products, and include therapeutic proteins (example filgrastim) and monoclonal antibodies (example adalimumab).
- What are biosimilar drugs and how do they compare to biologics?A biosimilar is not considered a “generic” in the same way that a traditional, small molecule drug (for example: ibuprofen or acetaminophen) is determined to be a generic. Biosimilars are "similar" because they are biologics that do not have to be exact copies of the active ingredient, as with small-molecule drug generics.
- What is the difference between Erelzi and Enbrel? - Drugs.comA biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological (in this case Enbrel). The FDA has determined there are no clinically meaningful differences between the biological product Erelzi and the original reference product Enbrel in terms of safety, purity, and potency.
- Cimerli: Uses, Dosage, Side Effects & Warnings - Drugs.comA biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. One example is Amjevita (adalimumab-atto), the first biosimilar approved for Humira (adalimumab) in 2016. Continue reading
- FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to StelaraJERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult ...
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