FDA, biosimilar
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The FDA said it proposed significant changes to simplify biosimilarity studies and reduce what it described as unnecessary clinical testing of the lower-cost “generic” alternatives to
7hon MSN
FDA to streamline approvals for generic biological drugs in latest move targeting health costs
The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate approvals for cheaper alternatives for medications used to treat a wide range of illnesses,
In new draft guidance, the FDA has taken steps to eliminate the clinical testing of biosimilars and to categorize all approved biosimilars as “interchangeable."
The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive for drugmakers to develop biosimilar medicines, the copycat versions of off-patent biologic drugs.
The age of biosimilars has come for gastroenterology. This includes interchangeable products, three of which are now on the market. How this will impact patient care in the near and distant future is the subject of much speculation. While an increasing ...
So far, the USFDA has approved 76 biosimilars but the market share of these remains below 20% with only 10% of the biologics losing patent protection having a biosimilar in development.