Romanian Society of Pharmaceutical Sciences

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INVESTIGATING THE PHYSICOCHEMICAL, NON-CLINICAL, AND CLINICAL CRITERIA FOR ASSESSING COMPARABILITY IN RANIBIZUMAB BIOSIMILARS: A COMPREHENSIVE REVIEW

AMMAR ALMAAYTAH*

Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan

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In recent decades, the development of monoclonal antibodies (mAbs) has broadened the therapeutic options available to clinicians for treating various conditions, including cancer, autoimmune and ophthalmic disorders. These antibodies and their derivatives such as Fragment antigen binding proteins are characterized by their large size and complex three-dimensional structures. Each antibody and its derivatives have a unique living cell production platform, making the precise replication of these complex molecules highly difficult. Ranibizumab lost its patent protection in the US and EU in 2022, allowing multiple pharmaceutical companies to introduce various copies into clinical practice, exhibiting varying degrees of quality. The introduction of these biosimilars, lacking comprehensive evidence of their comparability to the originator Ranibizumab, poses potential risks for patients, including issues related to efficacy, immunogenicity and potential toxicity. This review aims to equip pharmaceutical professionals and regulatory officers globally with essential technical requirements for conducting a comprehensive comparability exercise for Ranibizumab biosimilars. Drawing upon guidelines from the EMA and U.S. FDA, along with insights from current literature, the review seeks to provide a thorough analysis of various aspects of the ranibizumab comparability exercise, ensuring that the biosimilar product aligns with stringent quality standards comparable to the reference biologic.