1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

Certara Gets Further FDA Grant For Virtual Bioequivalence Studies

US Agency Offers Funding To Verify And Expand Biosimulation Models

 
• By Dave Wallace

The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.

Tablets Bottle Dollars
The FDA has granted Certara further funding • Source: Alamy

The US Food and Drug Administration has granted biosimulation specialist Certara further funding to verify and expand its models for assessing virtual bioequivalence, with an ultimate goal of helping to enable safer, faster and more cost-effective generic drug development.

Noting that the award represented the fourth FDA grant linked to the development of its Simcyp MechDermA model for assessing virtual bioequivalence, Certara explained that its modeling and simulation techniques – such as physiologically-based pharmacokinetic modelling – were intended to address the challenges of bioequivalence studies, including

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
Start Free Trial

Already a subscriber?

More from Regulation

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

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.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

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.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

More from Policy & Regulation

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

French Body Welcomes Call For Greater Uptake

 
• By Dave Wallace

French generics and biosimilar body Gemme has welcomed a call from the country’s audit court to improve uptake for off-patent medicines.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.