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« USPTO Extends Patent Prosecution Highway Pilot Programs | Main | IPLAC Patent Law Symposium 2011 »

October 13, 2011


It should be noted that only a small portion of biopharmaceuticals and absolutely no products regulated as biologics are approvable through 505(b)(2)! Thus, the title and most use of "biologics" in this article are wrong. 505(b)(2) only applies to those relatively few, generally simpler (e.g., insulin, somatropin, calcitonin) biopharmaceuticals regulated as drugs, not biologics, largely due to grandfathering and historical regulation of similar (including animal- and human-derived) products as drugs.

Biologics now have their own biosimilar approval pathway.

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