FDA Updates ‘Purple Book’ Database

After Recently Transitioning Biologics Lists To Online Data

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Laptop_Files
The FDA’s recently created online ‘Purple Book’ database gets an update • Source: Shutterstock

The “Purple Book” that keeps track of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations has been updated by the US Food and Drug Administration after recently becoming a searchable online database.

Overhauled in February 2020, the initial Purple Book database contained a limited data set that included all approved biosimilar products and their related reference products

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By 

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By 

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By 

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

More from Products

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

 

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By 

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”