The U.S. Food and Drug Administration (FDA) has approved Merilog, a biosimilar to the widely used insulin product Novolog ...

“The FDA has now approved three biosimilar insulin products to treat diabetes,” noted Peter Stein, M.D., director of the ...

FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its ...

"The FDA has now approved three biosimilar insulin products to treat diabetes," said Peter Stein, MD, director of the Office of New Drugs at CDER.

"The FDA has now approved three biosimilar insulin products to treat diabetes," said Peter Stein, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. This presents a golden opportunity for Contract Manufacturing ...

The FDA has approved two new biosimilars of denosumab to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung ...

The Food and Drug Administration (FDA) has designated Yuflyma ® (adalimumab-aaty) an interchangeable biosimilar to Humira ® (adalimumab).. Yuflyma, a tumor necrosis factor (TNF) blocker, was ...

This is the second biosimilar approved in the US from Amgen and Allergan’s partnership, which has already got a biosimilar to Roche’s Avastin (bevacizumab) cancer drug backed by the FDA. Amgen ...

2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA ...

The U.S. Food and Drug Administration has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin (bevacizumab) for intravenous use in cancer types including colorectal cancer, non-small cell ...