ABSTRACT:
This article particularly focuses on the Orange Book which is more formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations and also on the Purple Book-more formally known as List of Licensed Biological Products with Exclusivity of Reference product and Biosimilarity or Interchangeability Evaluations. Major topics covered in this article include: the legislative background of the ‘Orange Book’, safety and effectiveness, Hatch-Waxman Act, Patents and exclusivity comparisons, (ANDA) Abbreviated New Drug Application Patent Certification process, Contents of the Orange Book, Therapeutic Equivalence Code, Electronic Orange Book and about the Upgrade of Orange Book. In addition to this it also reviews the FDA’s Purple Book in detail. Since the use of biological products ha exponentially increased over the last few decades new regulations for reducing the cost of the original Biological Products have been framed among which the Purple Book was also one such stride. These types of reference guide will assist the pharmacists to provide leadership to the public about the substitution of appropriate generic and Biologic equivalents to the reference product. Hence let’s plunge into the article for more interesting information.