THE ASSESSMENT OF CURRENT REGULATORY GUIDELINES FOR BIOSIMILARS- A GLOBAL SCENARIO
Shaik Salman Basha*, S. M. Shakeel, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala
ABSTRACT
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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