1. Generics Bulletin
  2. >>Products

Another US Humira Biosimilar Approved As Formularies Offer Access

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

 
• By Dave Wallace

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/0.8ml formulation of adalimumab that will be available in both a self-administered pre-filled...

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 Products

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

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.

Generic Entresto Floods US Market Following MSN Patent Victory

 
• By Dean Rudge

As many as ten generic versions of Novartis’ blockbuster heart failure drug Entresto (sacubitril/valsartan) have begun entering the US market following recent key legal victories by MSN Laboratories.

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

 
• By Dave Wallace

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

More from Generics Bulletin

Who’s Hired? Rosemont Gains A Chairperson But Loses A CEO

 
• By Dave Wallace

In our latest roundup of off-patent industry appointments, we see management changes at UK liquids specialist Rosemont, a push into biosimilars from Korea’s Daewoong, and fresh appointments at firms including Meitheal, Celltrion, Accord, Alvotech, Civica and Centrient.

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

Amgen Stands Firm On IV Checkpoint Inhibitor Biosimilars

 
• By Dean Rudge

Amgen continues to advance its intravenous biosimilar programs for key immuno-oncology agents, including its ABP 234 biosimilar to Keytruda and ABP 206 biosimilar to Opdivo, despite growing interest in subcutaneous formulations enabled by hyaluronidase technology.