Guidance for monoclonal antibody use in animals approved
Monoclonal antibodies are immune proteins that recognise and bind to a specific target protein.
The first ever guidance for monoclonal antibody use in animals has been approved by the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP).
The guidance, prepared by CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies, takes the form of a question-and-answer document. It relates to the quality control for potential contaminants, stability testing, reproductive safety studies and data to address the potential for indirect adverse effects.
Monoclonal antibodies are immune proteins that recognise and bind to a specific target protein. Until recently they have not been used in veterinary medicine. In humans, however, they have been authorised for many years against cancer and diseases affecting the immune system.
Due to a lack of regulatory guidance, therapies that are new to veterinary medicine face particular challenges. But in February 2017, the first veterinary medicine containing a monoclonal antibody was recommended for approval by the CVMP.
Veterinary novel therapies refer to therapies that are either new, or new only to the veterinary sphere, but well known in the context of human medicine.
Interest and research into veterinary novel therapies have increased in recent years. Following a review of relevant scientific evidence, the CVMP identified monoclonal antibodies as one of the priority areas that would benefit from specific guidance.
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
