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Biosimilars Law Blog

Monthly Archives: January 2012

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

Posted in Global Comparisons

Global Dis-Harmonization of Biosimilar Naming and Labeling

The Food and Drug Law Institute held a recent “Dialogue” on the naming and labeling of biosimilars in the U.S. as the Food and Drug Administration (FDA) implements the abbreviated pathway for biosimilars authorized under the Biologics Price Competition and Innovation Act. While the representatives from FDA participated on both panels—naming and labeling, the remainder