The Purple Book: Evaluations, Approvals and recent updates

  • SubbaRam Prasad G
  • Naga Jyothsna B
  • Murali Krishna C
  • Raja Sekhar P
  • Rama Mohan Gupta V


The Purple Book is an informative database of all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. and allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). The current article emphasizes the significance of the Purple Book and the new law, The Purple Book Continuing Act enacted about approved patented biologic products, marketing status etc.  The Act codifies a number of FDA's current Purple Book practices, and imposes a new requirement for publishing the reference product sponsor's "patent lists" exchanged in the so-called "patent dance" of BPCIA biosimilar litigation. Biologics approved for 2020-21 are listed.

Keywords: CDER, USFDA, BPCIA, Biological products, Purple Book, FDA, CBER, Biosimilar product


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1. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry [Internet]. FDA; 2013 [cited 2021 May 13]. Available from:
2. US Food and Drug Administration.Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations [Internet]. FDA; 2020 Mar 08 [cited 2021 May 12]. Available from:
3. Kim, H., Alten, R., Avedano, L. et al. The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases. Drugs. 2020; 80: 99-113.
4. JDSUPRA. “Purple Book” Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect? [Internet]. JDSUPRA; 2021 Apr 08 [cited 2021 May 19]. Available from:
5. §262. Regulation of biological products. PHS Act § 351(l)(2)(A) (42 U.S.C. § 262(l)(2)(A)); supra n.11 [Internet]. GPO.GOV; 2010 [cited 2021 May 12]. Available from:
6. FDA. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes [Internet]. FDA; 2021 Jul 28 [cited 2021 Jul 30]. Available from:
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How to Cite
K, R. R., S. Prasad G, N. J. B, M. K. C, R. S. P, and R. M. G. V. “The Purple Book: Evaluations, Approvals and Recent Updates”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 32-36, doi:10.22270/ijdra.v9i3.480.