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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.
Highlights
By the end of the 20th century, advances in science and technology facilitated the development of complex biological molecules capable of modifying intercellular signaling pathways using a targeted approach not previously achieved with chemically synthesized drugs [1]
In a 2017 review, Moots et al found no differences in safety/efficacy outcomes with or without switching between the reference biologics adalimumab, infliximab, etanercept, and rituximab and their biosimilars [35]
The importance of postmarketing surveillance in identifying safety concerns related to intended copies was demonstrated with the rituximab intended copy Kikuzubam®, as reports of anaphylactic reactions in rheumatology patients switched to this biosimilar in the Mexican pharmacovigilance program resulted in its removal from the market [41, 42]
Summary
By the end of the 20th century, advances in science and technology facilitated the development of complex biological molecules capable of modifying intercellular signaling pathways using a targeted approach not previously achieved with chemically synthesized drugs [1] These innovations brought a class of biopharmaceuticals that revolutionized the treatment paradigm for a wide range of chronic inflammatory diseases. With limited biosimilar experience in North Africa, it is imperative that Healthcare Professionals (HCPs) gain a thorough understanding of these agents and the implications of their use The objectives of this narrative review are to define and describe the various classes of currently available biopharmaceuticals; summarize current regulatory requirements and provide an update on approval, globally and in the North African region; and present key issues related to biosimilar use from the perspective of practicing rheumatologists in North Africa. Many differences and similarities in clinical practice are evident between Western countries and North African countries, and may be of interest, such a comparison is beyond the scope of the current review
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