Boehringer Ingelheim receives CHMP recommendation for EU Cyltezo approval

Boehringer Ingelheim has announced that its new biosimilar therapy Cyltezo has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the marketing authorisation application of Cyltezo, which is designed to treat multiple chronic inflammatory diseases in adults and children.

Cyltezo is a biosimilar version of adalimumab, the multipurpose therapy marketed by AbbVie under the brand name Humira, and is used in the treatment of multiple forms of arthritis, as well as Crohn's disease, psoriasis, ulcerative colitis and hidradenitis suppurativa.

A comprehensive package was submitted to European regulators supporting the biosimilarity of Cyltezo to Humira based on analytical, pharmacological, non-clinical and clinical data.

Ivan Blanarik, senior vice-president and head of biosimilars at Boehringer Ingelheim, said: "The recommendation by the CHMP for Cyltezo is an important milestone for Boehringer Ingelheim, bringing us one step closer to providing our first biosimilar to healthcare providers and patients."

A final decision on approval is expected from the European Commission during the fourth quarter of 2017.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.