Humira One Year Out: The Largest LOE Event In US Pharma History

Amgen’s Amjevita Biosimilar Set To Launch On 31 January 2023 With Many More To Follow

Ahead of the first biosimilar Humira product set to launch in less than a year, In Vivo provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

Day 365 Day 1 Turning Blocks Hand
With Humira, the biosimilar market is set to 'ignite' in 2023 • Source: Frank Harms / Alamy Stock Photo

Not that it needed spelling out, but Organon’s CEO Kevin Ali wished to make sure there were no uncertainties. “That’s going to be the largest loss of exclusivity event in the history of the pharma market in the US,” he told attendees at the annual J.P. Morgan Healthcare Conference in January 2022. 

The arrival of the first biosimilar to AbbVie Inc.’s Humira (adalimumab) in exactly one year’s time is to mark...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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 Market Access

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

US Health System Redesign Critical, NAM’s Medical Experts Warn Trump Government

 
• By 

The whirlwind back-and-forth on US tariffs and Robert F. Kennedy jr.’s plans to deregulate health care have become all-preoccupying, but the National Academy of Medicine was first to set out President Trump’s health administration priorities.

Future Of 340B Rebate Models Hinges On Regulatory Decision Point

 
• By 

As pharmaceutical companies seek to transform how drug discounts are delivered under the 340B program, a federal ruling reinforces HRSA's authority. The industry must now wait for critical guidance from the Trump administration that could reshape compliance strategies and financial outcomes.

Digital Transformation At The FDA: Generative AI Set To Transform Drug Review Process

 
• By 

The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.

More from In Vivo

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By 

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By 

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.