Log In

 

Company Name : Boehringer Ingelheim

Monday, November 13, 2017 8:00PM IST (2:30PM GMT)

(BW)(BOEHRINGER-INGELHEIM)

Cyltezo®, adalimumab biosimilar from Boehringer Ingelheim, approved in Europe for the treatment of multiple chronic inflammatory diseases


The European Commission has granted marketing authorisation for a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases; Robust analytical, pharmacological, non–clinical & clinical data demonstrated the similarity of Cyltezo® to Humira®; Approval follows recent positive CHMP opinion1 and FDA approval2 of Cyltezo®


Ingelheim, Germany

Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.*

 

“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.”

 

Cyltezo® has been approved for the treatment of multiple chronic inflammatory diseases in adults, 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.

Cyltezo® has also been granted marketing authorisation for the treatment of paediatric inflammatory diseases, including* moderate to severe Crohn's disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).

 

The marketing authorisation of Cyltezo® was based on a comprehensive data package supporting the biosimilarity of Cyltezo® to Humira® comprising analytical, pharmacological, non-clinical and clinical data.

 

This included results from the pivotal Phase III study VOLTAIRE®-RA, which demonstrated clinical equivalence in efficacy of BI 695501 to the reference product in patients with moderate to severely active rheumatoid arthritis by meeting its primary endpoint. Additionally the study showed no clinically meaningful differences between BI 695501 and Humira® in terms of safety and immunogenicity.3

 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Cyltezo® on September 14th, 20171 and on August 25th, 2017, Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in the United States (U.S.). 2

 

Cyltezo® is not commercially available in Europe or the U.S. at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo® in the EU before expiration of the respective SPC for adalimumab in October 2018. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.

 

Intended audiences:

 

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

 

For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/Marketing-Authorisation-granted-for-Cyltezo

 

 

 

 


Click here for Media Contact Details
CONTACTS :

Media Contact
Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
www.boehringer-ingelheim.com


More News from Boehringer Ingelheim

21/11/2017 9:45AM

Boehringer Ingelheim Makes Many of Its Best Molecules Openly Available to the Scientific Community Via opnMe.com To Unlock Their Full Potential

Boehringer Ingelheim announced the launch of opnME.com, a new platform offering free and open access to selected pre-clinical molecules for non-clinical investigation to scientists worldwide. Through opnME.com, ...

15/11/2017 6:22PM

New RE-VERSE AD™ analyses provide additional insights on impact of Praxbind® (idarucizumab) in Pradaxa® (dabigatran etexilate) patients with gastrointestinal bleeding or needing emergency surgery

Additional analyses of patients in diverse emergency settings confirm that idarucizumab immediately reverses the anticoagulant effect of dabigatran in patients in emergency settings1,2 Sub-analyses from ...

15/11/2017 5:30PM

Jardiance® reduced risk of cardiovascular death in adults with type 2 diabetes and peripheral artery disease

New data showed that empagliflozin reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease. These results, from a ...

Similar News

21/11/2017 10:32AM

Mitsui Chemicals in Collaboration with Bilcare Introduces Chemipearl™ XSP in India: New High Performance Heat Seal Coating Based on Water Based Technology for Pharmaceutical Blister Packaging

Mitsui Chemicals, Inc. (TOKYO: 4183; President&CEO: Tsutomu Tannowa) announced the successful development of XSP series of ChemipearlTM which is a high performance “Water-based Heat Seal Coating” for ...

No Image

21/11/2017 9:45AM

Boehringer Ingelheim Makes Many of Its Best Molecules Openly Available to the Scientific Community Via opnMe.com To Unlock Their Full Potential

Boehringer Ingelheim announced the launch of opnME.com, a new platform offering free and open access to selected pre-clinical molecules for non-clinical investigation to scientists worldwide. Through opnME.com, ...