BI Gets EU OK for Biosimilar of AbbVie’s Humira

By Akia Thorpe -

November 16, 2017

The European Commission (EC) has approved Boehringer Ingelheim’s (BI’s) Cyltezo (adalimumab), a biosimilar to AbbVie’ Humira (adalimumab), for treating multiple chronic inflammatory diseases in adults and children. Humira is AbbVie’s top-selling drug with 2016 sales of $16 billion.

Cyltezo has been approved for treating multiple chronic inflammatory diseases in adults, including: moderate-to-severe active rheumatoid arthritis; psoriatic arthritis; moderate-to-severe active Crohn's disease; severe active ankylosing spondylitis (AS); moderate-to-severe active ulcerative colitis; severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; and non-infectious intermediate, posterior, and panuveitis.

The biosimilar has also been granted marketing authorization for treating pediatric 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).

Cyltezo was approved by the US Food and Drug Administration in August 2017. Cyltezo is another adalimumab biosimilar approved by the FDA and EC. In September 2016, Amgen received FDA approval for Amjevita (adalimumab-atto) and in April 2017, Amgen received EU authorization.

Cyltezo is not commercially available in Europe or the US at this time. BI says it does not intend to launch Cyltezo in the European Union before expiration of the respective Summaries of Product Characteristics, a legal document approved as part of the marketing authorization, for adalimumab in October 2018. BI is currently engaged in patent litigation with AbbVie in the US.

Source: Boehringer Ingelheim