14/15 December 2021
With the increasing number of biopharmaceutical products with an ending patent protection, more and more companies may choose to develop a biological medicinal product claimed to be "similar" to a reference medicinal product, which has already been granted a marketing authorisation. The authorities expect in such a case the demonstration of the similar nature of the two biological medicinal products by the submitting company. Comparability studies are needed to generate evidence substantiating that the biological medicinal product is similar to the chosen authorised reference medicinal product in terms of quality, safety and efficacy.
Therefore, the European authorities as well as the US FDA published several guidelines: e.g. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1, October 2014) or Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (FDA, April 2015).
The demonstration of the similarity of biological products appears much more difficult than the development of chemical generics, related to the higher complexity and variability of biological systems.
For additional support, the European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. In the foreword of the new guidance document, Prof. Guido Rasi, EMA Executive Director summarizes:
"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."
Collecting the contributions of the EMA, the European Commission and the experts from the member states, the new guide was prepared to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.
For more details please see the complete guide Biosimilars in the EU - Guide for healthcare professionals.