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1. www.fda.gov › drugs › therapeutic-biologics-applications-blaPurple Book: Lists of Licensed Biological Products

   www.fda.gov › drugs › therapeutic-biologics-applications-bla

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   3 sie 2020 · The Purple Book is a searchable online database that contains information about biological products, including biosimilar and interchangeable products, licensed by the FDA. It covers products regulated by CDER and CBER under the PHS Act.

   • Biosimilars

     FDA approved biosimilars are safe, effective treatment...

   • BLA

     Purple Book Database; Content current as of: 02/24/2020....

   • Purple Book Database

     The FDA Purplebook is a searchable online database...

   • Biosimilar Product Information

     The Purple Book Database contains information on all...

   • Background Information

     The “Purple Book” began as two lists (one for the CDER and...

2. purplebooksearch.fda.govFDA Purplebook

   purplebooksearch.fda.gov

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   The FDA Purplebook is a searchable online database containing information about licensed biological products, including biosimilar and interchangeable products.

3. www.fda.gov › drugs › biosimilarsBiosimilar Product Information | FDA

   www.fda.gov › drugs › biosimilars

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   24 sie 2023 · The FDA provides a list of biosimilar products that have been approved and their reference products, as well as links to more information. A biosimilar is a biological product that is highly similar to an existing FDA-approved product.

4. www.fda.gov › drugs › biosimilarsBackground Information: (Purple Book)

   www.fda.gov › drugs › biosimilars

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   3 sie 2020 · The Purple Book database lists FDA-licensed biological products, including biosimilars and interchangeables, and their reference product exclusivity status. Learn about reference product exclusivity, biosimilarity, interchangeability, and how to access the database.

5. www.bbcic.org › resources › fda-guidancePurple Book: Lists of Licensed Biological Products with ... -...

   www.bbcic.org › resources › fda-guidance

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   The Purple Book is a nickname for electronic lists of biological products licensed by FDA, including biosimilars and interchangeables. It shows the date of licensure, exclusivity, and reference product information for each product.

6. content.govdelivery.com › accounts › USFDAUpdates to the Purple Book: Database of Licensed Biological...

   content.govdelivery.com › accounts › USFDA

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   25 cze 2021 · The Purple Book database contains information about all FDA-licensed biological products, including licensed biosimilar and interchangeable products, and their reference products, and information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products.

7. www.nature.com › articles › s41587/021/01204-yRecent Orange and Purple Book legislation suggests a need to...

   www.nature.com › articles › s41587/021/01204-y

   15 lut 2022 · The US Food and Drug Administration (FDA) maintains two formal, comprehensive lists of approved drug and biologic products, collected together in registries known as the Orange Book and...