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Shaik Salman Basha*, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala


The development of biosimilar drug products will be an increasingly important area in drug regulation and clinical availability. All over the world, countries have been putting regulations in place and are beginning to evaluate biosimilars for marketing approval. The study objectives are to describe the regulatory procedures, quality, safety, efficacy and compare the regulatory aspects of biosimilar guidelines in different countries. To attain the desired objectives of the study review of national legislative documents and guidelines were studied. The drift towards harmonization is to promote public health by ensuring quality, safety and efficacy of biosimilars. The bottom line behind a unified framework of guidelines for biosimilars is to prevent duplication of pre clinical studies, clinical trials, comparability studies, demonstration of biosimilarity to reference biological product without compromising on safety and efficacy aspects, which is obligatory for registration and marketing of biosimilars in any country. Besides, large emerging economies such as China and Brazil, India are currently lagging behind in terms of implementation of regulations and need to act rapidly in developing appropriate regulations for biosimilar product approval.

Keywords: Biosimilar, biologic drug products, biosimilarity, marketing approval, harmonization.

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