Biological medicines, often produced by cutting-edge biotechnology, have transformed the outlook for patients with many chronic and often disabling conditions. An increasing number of biological medicines are ‘biosimilars’ - medicines highly similar in all essential aspects to an already approved biological medicine.
The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety.
As healthcare professionals are at the forefront of patients’ care, it is vital that they have access to reliable information on these medicines: what they are and what scientific principles support their clinical development, approval and safety monitoring. This guide has therefore been prepared with the important objective of providing healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.