Center for Drug Evaluation Research Licensed Biological Products

$79 / year

This dataset contains a list of biological products regulated by the Center for Drug Evaluation and Research (CDER). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products.

Complexity

Why Purple? The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” Using a color for the nickname of the list draws upon FDA’s (Food and Drug Administration) long-held practice of using “The Orange Book” to refer to “Approved Drug Products with Therapeutic Equivalence Evaluations,” the Agency’s reference listing of all drugs approved under the Federal Food, Drug and Cosmetic Act. Over the years, health care professionals and other stakeholders have come to use the term “Orange Book” in place of this longer, official title. FDA wanted a similarly user-friendly term for a reference listing biologics, biosimilars, and interchangeable products. During a meeting, a staff member said, “how about purple?” Ever since, it is called the “Purple Book.”

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 lists include 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 will also enable a user to see 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). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

For products licensed under section 351(a) of the PHS Act, the lists identify the date the biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. If FDA has determined that a biological product is protected by a period of reference product exclusivity, the list will identify the date of first licensure and the date that reference product exclusivity (including any attached pediatric exclusivity) will expire.

Date Created

2014-09-09

Last Modified

2016-06-04

Version

2016-06-04

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Purple Book, BLA Products, Biosimilar Products, Biosimilar Drug Products, Biologic Drugs, Licensed Biological Products, Interchangeable Biological Products, Interchangeable Drugs, FDA Purple Book

Other Titles

CDER List of Licensed Biological BLA Products, CDER List of Licensed Biological Biosimilar Products, CDER List of Licensed Biologic Drugs and Products

Name Description Type Constraints
License_Application_Tracking_NumberBiologic License Application Submission Tracking Numberintegerrequired : 1 level : Nominal
Generic_NameThe nonproprietary name designated by FDA for a biological product at the time of licensure under the PHS Act (section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k) of the FD&C Act).stringrequired : 1
Brand_NameBrand/Trade Namestringrequired : 1
Date_of_LicensureThe date the application was approved/licensed for marketing. Date of licensure for each application was identified through FDA records.daterequired : 1
Date_of_First_LicensureThe date from which reference product exclusivity began to run.date-
Reference_Product_Exclusivity_Expiry_DateThe reference product exclusivity expiry date indicates (1) the date that is 12 years from the date of first licensure as described in 351(k)(7); plus (2) any pediatric exclusivity granted pursuant to section 505(A) of the FD&C Act, if applicable.date-
Interchangeability_or_BiosimilarityIdentification of those biologic license application's approved/licensed under 351(k) that were licensed as either interchangeable or biosimilar to the reference product. Such products will be listed under the reference product identified in the 351(k) application. Abbreviations: I means Interchangeable, B means Biosimilarstring-
Is_Withdrawn_from_Being_MarketedExplains whether Biologic License Application has been withdrawn and is no longer being marketed. This does not specify whether withdrawn for reasons of safety and/or effectiveness.boolean-
License_Application_Tracking_NumberGeneric_NameBrand_NameDate_of_LicensureDate_of_First_LicensureReference_Product_Exclusivity_Expiry_DateInterchangeability_or_BiosimilarityIs_Withdrawn_from_Being_Marketed
103575abciximabReoPro1994-12-22false
103950anakinraKineret2001-11-14false
125521ixekizumabTaltz2016-03-22false
125554nivolumabOpdivo2014-12-22false
125118abataceptOrencia2005-12-23false
125057adalimumabHumira2002-12-31false
125387afliberceptEylea2011-11-18false
125084cetuximabErbitux2002-12-04false
103749daclizumabZenapax1997-10-12true
103795etanerceptEnbrel1998-02-11false