Background and key issues congressional research service summary a biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. The fda states that the lists will be updated periodically. The purple book will also enable a user to see whether a biological product licensed under section 351k of the phs act has been determined by fda to be biosimilar to or interchangeable with a reference biological product an alreadylicensed fda biological product. The purple book lists biological products, including biosimilar biological products, licensed by the fda under 351a or 351k of the phs act. The fda is working to expand the purple book by transitioning from the current list format to a searchable online database. The impact of reformulation strategies on pharmaceuticals. To learn about our use of cookies and how you can manage your. The fda developed these lists to serve as a resource to help users find out if the agency has determined a biological product to be biosimilar to or. The purple book lists biological products, including biosimilar biological products, licensed by the. The food and drug administration fda or agency announced the completion of the first phase of the enhanced purple book on february 24, 2020. The socalled purple book is a list of all licensed biologic products and is a reference guide for patients, providers, payers, and manufacturers. Because they are produced in living organisms, biologics are difficult to replicate and can be costly.
News fda gives biosimilars a boost by expanding database. Comparable to the orange book, the purple book will help pharmaceutical enterprises determine if a particular biologic product has been designated by the fda to be biosimilar to. Todays fda action to enhance the purple book is a boon to those seeking to bring biosimilars to americas patients. In september 2014, the us fda published its first edition of the socalled purple book, with the rather lengthy title lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. The orange book has long been used by regulators and doctors to look up approved drugs and their therapeutic equivalents. Fda has regulated gene therapies like other biologic products, includes gene therapy in its own definition of biologics, and has already listed yescarta and kymriah in the socalled purple book, fdas compilation of products it. What this comes down to is specific biologics will be pulled from the fdas orange book on march 23, 2020 and placed into the purple book. Fda launches purple book database of biological products. The purple book is available as lists and a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed. The purple book is available as lists and a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed approved by the fda under the public. Dec 12, 2018 what this comes down to is specific biologics will be pulled from the fdas orange book on march 23, 2020 and placed into the purple book. Nov 17, 2016 it is important to note that the purple book does not list all approved biologics, only those approved under section 351.
Fda move opens door to biosimilar insulins, other biologics. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. 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. Sep 15, 2014 on september 9, 2014, fda released the first edition of the purple book, which is the analogue to the orange book for biologics. All subsequent applicants that follow on wont be able to depend on these new drug applications ndas for approval but will have to follow a biosimilar pathway for approval. Unlike the fdas orange book for small molecules, the purple book for biologics contains no patent information. It lists very specific information with regard to both the reference biologics and biosimilars. The purple book, in addition to the date licensed, also includes whether a biological product licensed under section 351k of the phs act has been determined by fda to be biosimilar to or.
Fitzpatricks biologicshq search for biologic drug patent. Jun 23, 2015 the purple book is an important compendium of fda approved biological products and their biosimilar and interchangeable products. While the orange book lists small molecule reference listed drugs and their approved counterpart generic drugs, the purple book lists licensed biologics and will list the corresponding licensed biosimilars once any are approved in due course. Manufacturers should consult this reference when submitting a 351k. While the fda has a website to search the orange book, no equivalent search mechanism exists for the purple book. Product and company page search results are reported for fda approved indications, abla and 505b2 activity, approved foreign biosimilars, iprs and u. The fda for the first time has published a reference list for biologics, known as the purple book, that will list all brand products and any biosimilars with which they are interchangeable. This update creates a single searchable electronic database that identifies each biosimilar and interchangeable biologic with its reference product, increasing transparency for patients, providers, payers, manufacturers and other stakeholders. Fda approves the first gene therapy to treat an inherited. Furthermore, any unexpired period of exclusivity with the exception of pediatric or orphan drug exclusivities associated with approved ndas for biologics will cease to have effect on the. Jan 03, 2018 fda has regulated gene therapies like other biologic products, includes gene therapy in its own definition of biologics, and has already listed yescarta and kymriah in the socalled purple book, fdas compilation of products it has licensed under the phsa. The purple book contains information on biological product names, type of biologics license application submitted to the fda, the strength of the biologic, the.
Fda is transitioning the current table format purple book. Similar to small molecules, biologics can get pediatric exclusivity that attaches to data exclusivity periods. The purple book is an easytoremember nickname for the lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations. Thus, the purple book is the orange book for biologics and can be used similarly to determine which biologic is biosimilar to or. Sep 04, 2018 under the bpcia, the fda purple book is the published agency reference on biosimilars. Information on when biosimilars launch, however, will not be included in the purple book. The purple book consists of two lists organized by fda center.
Sep 16, 2014 instead, the fda has provided two lists of biologics, depending upon which department of the fda has approved the product. How the purple book continuity act could challenge. Under the bpcia, the fda purple book is the published agency reference on biosimilars. The purple book is available as lists and a database of fda licensed approved biological products, including biosimilar and interchangeable products. The purple book includes the date a biological product was licensed under 351a of the phs act and whether fda evaluated the biological product. Fda introduces purple book for biologics food, drugs. Sep 26, 2014 the book will serve as a therapeutic equivalence guide for biologics and biosimilars and will function much like fdas orange book for chemical products. The purple book includes the date a biological product was licensed under 351a of the phs act and whether fda evaluated the biological product for reference product exclusivity under section 351. Feb 25, 2020 the us fda has overhauled its purple book to make it a searchable database of biologics information. Instead, the fda has provided two lists of biologics, depending upon which.
The purple book is intended to be used in the same way. Fda comes out with purple book to catalog biologics and biosimilars in a move that heralds greater momentum toward regulating biosimilars, the food and drug administration. The purple book, which is more formally known as lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations, and that shares a shorthand name with other government publications see, e. The fda then determines the biosimilarity of a compound according to following categories. The guidance also explains that the fda will remove biologic products approved through ndas from the orange book and into the purple book on march 23, 2020. The purple book contains information on biological product names, type of biologics license application submitted to the fda, the strength of the biologic, the dosage form, product presentation. Center for drug evaluation and research cder and the center for biologics evaluation and research cber. On september 9, 2014, fda released the first edition of the purple book, which is the analogue to the orange book for biologics. This new publication, like its wellestablished orange book counterpart, will list approved biologic drug products and also their. The purple book is available as lists and a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed approved by the fda. Beginning on or shortly after march 23, 2020, healthcare providers can find transition biological products in the purple book, which identifies licensed biological products by brand name and. The lists include the date a biological product was licensed under 351a of the phs act and whether fda evaluated the biological product for reference product exclusivity.
Fda updates purple book for biologicals and biosimilars. For this purpose, the fda has issued a purple book that includes currently approved cder and cber biologics. The release of the purple book comes just weeks after fda received two applications for approval for zarzio and remsima, which were submitted through the 351k pathway as biosimilars to. Separate lists are maintained for biological products regulated by the center for drug evaluation and research cder and the. Instead, it merely lists approved biologics, biosimilars, and interchangables. Fda publishes purple book for biosimilars knobbe martens.
However, as yet there are no interchangeable products listed in the purple book. Information contained in the venable fitzpatrick biologicshq database relates to fdaapproved drug products listed in the cder purple book. Purple book is a list of innovator biological products, including biosimilars and interchangeable biological products licensed by fda under the phs act and the orange book is a list of generic drugs approved by fda. The fdas purple book lists all biologics with notations on which medications are originators, biosimilars, or interchangeables.
May 02, 2019 under the bpcia, the fda purple book is the published agency reference on biosimilars. 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. Fda comes out with purple book to catalog biologics and. Apr, 2020 because they are produced in living organisms, biologics are difficult to replicate and can be costly. Food and drug administration is upgrading the purple book, otherwise known as the database of fdalicensed biological products, in phases, starting today, with full search functionality. Fda publishes purple book to catalog biologics, interchangeable and biosimilar products the us food and drug administration fda recently published its first lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations, otherwise known as the purple book. Fdas purple book for biologicspatents not included food. Thus, the purple book is similar to the orange book in that it lists certain products, their approval dates, and exclusivity information. Information contained in the venable fitzpatrick biologicshq database relates to fda approved drug products listed in the cder purple book. On its own initiative, the fda first published the purple book in 2014 one year before the 2015 approval of the first biosimilar product. Fda approves the first gene therapy to treat an inherited disease. May 07, 2019 on its own initiative, the fda first published the purple book in 2014 one year before the 2015 approval of the first biosimilar product. Thus, the purple book is the orange book for biologics and can be used similarly to determine which biologic is biosimilar to or interchangeable with an originator 19, 27. This resource provides lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations.
Lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations to a. This reference guide will assist pharmacists in providing the leadership necessary to develop and implement appropriate pharmacovigilance programs for biological products. Unlike the orange book the fdas patent register for smallmolecule drugs, the fdas purple book for biologics does not list patents, making. The purple book is available as lists and a database of fdalicensed approved biological products, including biosimilar and interchangeable products.
Oct 21, 2014 the purple book is meant, at a fundamental level, to be the biological equivalent of the orange book. The book will serve as a therapeutic equivalence guide for biologics and biosimilars and will function much like fdas orange book for chemical products. Fda debuts purple book for biologicals and interchangeable biosimilars. Instead, the fda has provided two lists of biologics, depending upon which department of the fda has approved the product.
The purple book is available as lists and as a searchable, online database that contains information about biological products, including any biosimilar and interchangeable biological products. The purple book, also known as the lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations, made its debut on fdas website earlier this month. Product and company page search results are reported for fdaapproved indications, abla and 505b2 activity, approved foreign biosimilars, iprs and u. Jul 19, 2019 unlike the orange book the fdas patent register for smallmolecule drugs, the fdas purple book for biologics does not list patents, making it somewhat more difficult for potential.
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