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- Biosimilars | FDA
Biosimilars increase access to lifesaving medications at potentially lower costs Explore the website to learn more about biosimilars and to access all FDA’s educational resources for health
- Biosimilar - Wikipedia
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company [1]
- Biosimilar Medicines - American Cancer Society
Biosimilars are more affordable alternatives to a specific class of medicines called biologics, including some immunotherapies used to treat many types of cancer While they are not exact copies, biosimilars follow strict FDA guidelines to ensure they work the same and are just as safe as brand name biologic medicines What is a biosimilar?
- What are biosimilar drugs and how do they compare to biologics?
A 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 The most recent biosimilar approval was Starjemza (ustekinumab-hmny), an interchangeable biosimilar to Stelara, on May 22, 2025
- An Overview of Biosimilars—Development, Quality, Regulatory Issues, and . . .
Biosimilars undergo extensive comparability studies to demonstrate their high similarity to the reference product in terms of quality, efficacy, and safety
- 20 Common Biosimilar Drugs in the U. S. - GoodRx
Many biosimilar drugs are available in the U S Between 2015 and 2022, 40 biosimilars were approved for use Top examples include Inflectra, Mvasi, and Zarxio A few interchangeable biosimilars, like Semglee and Cimerli, are also available
- What are Biosimilars and Biologics? | Pfizer Biosimilars
Biosimilars (and reference biologics) are created in living cells and require significant expertise and state-of-the-art technology in development and manufacturing
- Biosimilars 101 | SmithRx
Biosimilars are highly similar versions of biologic drugs and are designed to work just like the reference products in terms of safety, strength, dosage, and clinical outcome - but at a significantly lower cost Since biologics come from living organisms, no two batches are completely identical
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