Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown

US Launch Date Matches That Of BI’s Cyltezo Interchangeable Humira Biosimilar

Alvotech and AbbVie have settled all of their legal disputes over Alvotech’s AVT02 biosimilar rival to Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm’s US entry date provided by the settlement matches that of Boehringer Ingelheim’s interchangeable Cyltezo lower-strength adalimumab biosimilar.

Knights Chess Pieces Black White Face Off
Alvotech and Boehringer Ingelheim could launch rival interchangeable Humira biosimilars on the same date • Source: Thomas LENNE / Alamy Stock Photo

A face-off in the US between two different strengths of interchangeable Humira (adalimumab) biosimilars could be on the cards for 1 July 2023, after Alvotech settled all of its legal disputes with originator AbbVie, gaining a launch date that matches that of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) version.

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

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

 
• By 

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Cardinal Looks Ahead To A New Decade For US Biosimilars

 
• By 

In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.

More from Products

Regulatory Recap: UK To Capture £1bn Savings With Framework For Best-Value Biologics

 

Generics Bulletin reviews global regulatory developments across the world.

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By 

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

Tevogen Launches Generics-Focused Initiative As Trump Eyes Pharma Tariffs

 
• By 

As the Trump Administration continues to send ripples across industries, Tevogen has launched a new generic drugs-focused endeavor that plans to reshore production to the US.