The development process differs between reference biologic and biosimilar medicines as they have different objectives to meet. During the development of an originator/reference biologic medicine, the emphasis is on clinical studies to establish the clinical benefit of the medicine. As the objective of biosimilar development is to establish similarity with the reference product, the focus is on the comprehensive analytical and comparative studies required to validate this, with a smaller number of clinical studies required. A product will only be granted approval as a biosimilar if it meets the parameters defining similarity and has been found to have had no significant differences in quality, safety or efficacy. The reference product established the clinical benefits at the time of its approval and since then, has continued to do so through clinical experience and human safety databases. This information can be extrapolated to the biosimilar21,22.
Comparison of the development pathway of reference biological vs biosimilar medicines