Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

The U.S. Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the biosimilar applicant's notice of commercial marketing is proceeding through the Supreme Court.

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