CHMP recommends Cyltezo (adalimumab biosimilar) to treat multiple chronic inflammatory diseases based on clinical equivalence to Humira (adalimumab), the reference product.- Boehringer.

Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children. The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

The Marketing Authorisation Application (MAA) for Cyltezo was based on a comprehensive data package supporting the biosimilarity of Cyltezo to Humira (adalimumab) based on analytical, pharmacological, non-clinical and clinical data, including results from the pivotal Phase III study VOLTAIRE -RA1, which demonstrated clinical equivalence of Cyltezo to the reference product in people with moderate to severely active rheumatoid arthritis. The pivotal phase III study met its primary endpoint showing no clinically meaningful difference in efficacy between Cyltezo and Humira in terms of safety and immunogenicity.

The CHMP also recommends approval of Cyltezo 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).