MHRA guidance on the licensing of biosimilar products

Paul Fleming, Technical Director, British Biosimilars Association (BBA), said: “We are very supportive of the new MHRA guidance as when implemented, it will create a breakthrough opportunity for UK to become the first country where new biosimilar medicines are made available to patients. This is particularly important in a post-Brexit environment

“The substance of the guidance builds on 15 years of positive NHS clinical experience in switching patients to biosimilar medicines and also the results from tracking patient outcomes through follow up clinical studies. It is good science and clinical experience which has led the MHRA to concluding that in most cases a comparative efficacy trial is not necessary for regulatory approval. The pharmaceutical companies which develop biosimilar medicines undertake a highly detailed and systematic series of comparability studies using state of the art analytical techniques. It is this robust and rigorous data which provides the regulatory confidence.”