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Biosimilars Law Blog

Tag Archives: Public Health Service Act

Posted in News & Events

Biosimilars: Who’s Who at FDA?

According to several recent presentations by U.S. Food and Drug Administration (FDA) officials, the agency has established three committees charged with discussing and coordinating issues related to biosimilars to ensure consistency in the regulatory approach and guidance to sponsors.  While FDA set up this infrastructure some time ago, with the issuance of the Draft Guidances

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