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what is USFDA purple book
19 Nov 2019

What is USFDA Purple Book? What it’s significance?

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).

The Purple Book includes the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

The Purple Book, in addition to the date licensed, also includes whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).

What is orange book?

The Orange Book is a list of drugs that the U.S. Food and Drug Administration (FDA) has approved as both safe and effective. Formally called Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book does not include drugs only approved as safe

What is the difference between Orange Book and Purple Book of USFDA?

  • The Orange Book is an important publication published by the FDA that provides the standard reference for generic drug substitution.
  • On the other hand purple Book is an important publication published by the FDA that provides the standard reference for biosimilar and interchangeable biological products substitution.

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