1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Fresenius Is Latest To File Denosumab With US FDA

While Henlius Confirms EMA Acceptance Of Its European Prolia/Xgeva Biosimilar Filing

 
• By Dave Wallace

With activity around denosumab biosimilars continuing to heat up, Fresenius Kabi has announced US FDA acceptance of its filing, while China’s Henlius says the EMA is reviewing its own biosimilar submission.

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
Fresenius has filed its denosumab biosimilar in the US • Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

Fresenius Kabi has become the latest company to confirm a US Food and Drug Administration filing for a Prolia/Xgeva (denosumab) biosimilar, announcing that its version has now been accepted for review by the US agency.

The firm had reported midway through last year that its FKS518 candidate referencing Prolia (denosumab) successfully met its primary and...

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 Biosimilars

Lupin Couples Up With Sandoz For Global Lucentis Biosimilar Deal

 
• By Urtė Fultinavičiūtė

Sandoz snatched commercialization rights to Lupin’s ranibizumab biosimilar across multiple global markets, while also taking steps to decarbonize its operations in Europe.

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 
• By Urtė Fultinavičiūtė

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By Dean Rudge

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Kashiv Joins Forces With MS Pharma In MENA For Omalizumab

 
• By Dave Wallace

Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.

More from Products

Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By Dean Rudge

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By Dean Rudge

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.