The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorisation Application for Germany-based Boehringer Ingelheim's Cyltezo (adalimumab biosimilar) intended to treat multiple chronic inflammatory diseases in adults and children, it was reported yesterday.

The decision on the approval is expected in the fourth quarter of 2017.

The CHMP also recommends approval of the product 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 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-RA, which demonstrated clinical equivalence of BI 695501 to the reference product in people with moderate to severely active rheumatoid arthritis.