Boehringer Makes Case For Interchangeable Adalimumab Biosimilar

Voltaire-X Switching Study Concludes Similar Clinical Outcomes

Boehringer Ingelheim, which is looking to be among the limited players to offer an interchangeable biosimilar in the US, has reported positive switching data from the company’s “first-of-its-kind” Phase IIIb Voltaire-X study.

boehringer hq
AbbVie believes two Humira biosimilars will be designated interchangeable with Humira • Source: Shutterstock

Boehringer Ingelheim has boosted its chances of winning a landmark designation for interchangeability for its Cyltezo (adalimumab-adbm) biosimilar later this year after reporting positive data from the firm’s “first-of-its-kind” Phase IIIb Voltaire-X switching study.

According to the German firm, data from the 32-week trial concluded that switching several times between Cyltezo and AbbVie’s Humira reference brand “produced similar clinical outcomes in terms of pharmacokinetics, efficacy,

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

‘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.

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By 

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

More from Products

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.

Teva’s Uzedy Continues Surge As Olanzapine LAI Filing Nudges Closer

 
• By 

Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By 

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.