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Biosimilars Law Blog

Tag Archives: Food Drug and Cosmetic Act

Posted in News & Events

FDA Activities During Government Shutdown

The U.S. Food and Drug Administration staff will continue User Fee supported activities and vital consumer protection activities during the government shutdown.  FDA staff, including review divisions and chief counsel’s office, will continue work on regulatory activities covered by user fees under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA),

Posted in Biosimilars vs. Generics

Why are generic drugs the ‘same’ and biosimilars only ‘similar’ to their corresponding reference products?

It’s the law and science. The regulatory world of biological drugs is more complex and perhaps less clear than for the world of small molecule drugs. This is particularly true in the U.S. where, for historical reasons, biologics and small molecule drugs are regulated under separate statutes, the Public Health Services Act (PHSA) 351 and