Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies

Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.

sunrise over Greece
WITH AN INTERCHANGABLE DESIGNATION TO Abbvie’s HUMIRA, BOEHRINGER INGELHEIM’S CYLTEZO COULD HEARLD THE DAWN OF A NEW ERA FOR BIOSIMILARS IN THE US. • Source: Alamy

Boehringer Ingelheim GmbH’s Cyltezo has won an interchangeable biosimilar designation to AbbVie Inc.’s Humira from the US Food and Drug Administration. It’s an achievement that not only heralds the likely decline of earth’s mightiest franchise, but also paves the way for many more interchangeable products since it offers the first-ever published data on what a successful switch study looks like.

FDA granted Cyltezo (adalimumab-adbm) the interchangeable designation on 15 October, but the product’s commercial license won’t begin until 1 July...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Approvals

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By 

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

More from Product Reviews

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.