Regulatory Perspectives on Biopharmaceuticals for Chronic Inflammatory Diseases in North Africa: A Narrative Review

Abstract

Introduction of innovative biopharmaceuticals has dramatically changed the treatment of chronic inflammatory diseases, but access to these very effective agents may be limited by economic constraints in some regions. The development of biosimilar products at a lower cost may allow wider access to treatment, but rigorous scientific evaluation is required to ensure similar quality, efficacy, and safety. The World Health Organization, European Medicines Agency, and United States Food and Drug Administration have created stringent guidelines for biosimilar regulatory approval, stipulating that high similarity be demonstrated in comprehensive comparability studies. Although these regulatory standards have been adapted in many countries, the legal/regulatory frameworks required for biosimilar authorization remain in development elsewhere, including North Africa. In some countries, “intended copies” are available despite inadequate evidence of comparability to the reference product and failure to satisfy biosimilar regulatory requirements. In North Africa, as the regulatory pathway for biosimilars is established, regulators will address several important challenges, including criteria for comparability, switching/substitution, post-marketing monitoring/risk management, and product naming conventions. Caution is advised to ensure that lower cost and broader access are not achieved at the expense of patient safety, and educational initiatives should be undertaken for clinicians/patients. In this review, we define the various types of biopharmaceuticals currently available for the treatment of chronic inflammatory disease, provide an overview of regulatory requirements for biosimilar approval and an update on the availability of these agents globally and in North Africa, and discuss crucial concerns related to their use from the viewpoint of North African rheumatologists.