Boehringer celebrates EU approval of Humira biosimilar

Boehringer Ingelheim has announced that Cyltezo, its biosimilar of Abbvie’s Humira, has received marketing authorisation approval from the European Commission, confirming that is comparable in safety and efficacy to its originator product.

The decision was made based on results from the Phase 3 VOLTAIRE study which confirmed Cyltezo’s clinical equivalence to Humira in patients with moderate to severely active rheumatoid arthritis.

In adults, the drug was approved for a range of multiple chronic inflammatory diseases, including:

Moderate to severely active rheumatoid arthritis 

Psoriatic arthritis 

Moderate to severely active Crohn's disease 

Severe active ankylosing spondylitis (AS)

Moderate to severely active ulcerative colitis 

Severe axial spondyloarthritis without radiographic evidence of AS

Moderate to severe chronic plaque psoriasis

Moderate to severe hidradenitis suppurativa

Non-infectious intermediate, posterior and panuveitis

In paediatric patients, the drug was also approved for moderate to severe Crohn’s disease in children six and older, severe chronic plaque psoriasis in children aged four and older, enthesitis-related arthritis in children aged six and older, and polyarticular juvenile idiopathic arthritis in children aged two and older.

"Cyltezo is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo®. We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world."