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Category Archives: Biosimilars vs. Generics

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Posted in Biosimilars vs. Generics

GPhA Petitions FDA Not to Distinguish Biosimilars by Unique Non-Proprietary Names

The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic.  FDA has not articulated a policy for naming of biologics, biosimilars and interchangeable biosimilars, although they asked for input on the topic in the Public Meetings and

Posted in Biosimilars Patent Exchange, Biosimilars vs. Generics

If you missed the Maximizing Patent Life Cycles panel discussion, you may want to read this

I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you missed it, “The Pink Sheet” covered the event in its article “FDA Denies Veramyst NCE Exclusivity, Revokes Torisel Exclusivity,” which expands upon several recent decisions from FDA on

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