Résumé
The objective of this thesis is to show, in the specific context of the teriparatide molecule indicated for the treatment of osteoporosis, the different regulatory aspects of the development of a biosimilar. The modalities of the biosimilar product comparability exercise in terms of quality, non-clinical and clinical are presented. The economic challenge of similar biological products is also discussed with the impact it generates on the healthcare system and patients. The regulation and market access of these biosimilars are constantly evolving and constitute real challenges for the pharmaceutical industries, especially since teriparatide is a unique case in the world where the molecule also exists in a generic form and is therefore derived from chemical synthesis.