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In Q2, the FDA approved two biosimilars in the ustekinumab and bevacizumab markets and four biosimilars were launched within ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include ...
On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public ...
The 2024 approvals included significant milestones in the biosimilar sector, with the FDA granting approval for the first biosimilar of Stelara, Wezlana and the first denosumab biosimilars, Wyost and ...
Tiffany E Jiang , Reshma Ramachandran , and Joshua J Skydel argue that US requirements for interchangeability are not supported by evidence and hamper use of biosimilars Biological medicines ...
Biosimilar drugs are drugs that are a lot like biologics, but maybe not identical. Learn why this matters inside.
Biosimilars with short development period and high success rate of development and approval compared to new drugs are ...
Biosimilar, not bioidentical? “Molecular structures of small-molecule drugs are specified exactly. Even a small change… could radically alter their function in the body,” Wahl says.
As with other therapeutic categories, penetration of biosimilar insulin products in the European market long predates the U.S. Across Europe, biosimilar insulin products began to launch in 2015.
Whether it is the biosimilar status, or the interchangeable designation, or—also likely—simply lower-price contracting, pharmacy benefit managers have started to embrace this product.
Biosimilar Approvals And The BPCIA: Too Soon To Give Up Jonathan J. Darrow July 19, 2019 10.1377/forefront.20190718.722161 Add to favorites ...
Although biosimilar-to-biosimilar switching is not covered by health regulations or guidance, a systematic literature review suggests the practice is safe and effective, according to data ...