Another US Humira Biosimilar Approved As Formularies Offer Access

While Alvotech And Stada Broaden Reach Of Higher-Strength Adalimumab In Europe

As Fresenius Kabi receives US FDA approval for its Idacio rival to Humira, positive developments are being seen in terms of adding adalimumab biosimilars to local formularies. Meanwhile, in Europe Stada and Alvotech have broadened access to their Hukyndra high-concentration version.

Fresenius Kabi logo on building
Fresenius Kabi has received US approval for its Idacio biosimilar • Source: Shutterstock

The latest approval for a Humira (adalimumab) biosimilar has been issued by the US Food and Drug Administration, this time for Fresenius Kabi’s Idacio (adalimumab-aacf) version of the top-selling biologic that is due to face US competition in 2023.

Fresenius said that Idacio – a citrate-free 40mg/0

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 Products

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By 

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

 

With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

More from Generics Bulletin

Biocon Eyes Fundraising Round Amid Discussions On Merger With Biosimilars Branch

 

As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

 
• By 

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.

Viatris Awaits ‘Significant Rebound’ At Indore In 2026 After Painful Q1 Bite

 
• By 

Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.