Journal: Journal of Pharmacy Research

Article Id: JPRS-DIR-000094
Title: The assessment of current regulatory guidelines for Biosimilars - A Global Scenario
Category: Drug Information Research
Section: Review Article
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    Background: With the increasing number and generally high cost of biologic drug products and the impending loss of patent protection by many of them, it seems virtually certain 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 Methods: 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. Results: A sure prediction is that regulations governing biosimilars will continue to evolve and will become more detailed and specific as more experience is gained with these products and harmonization can be possible. Discussion: 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. Conclusion: A sure prediction is that regulations governing biosimilars will continue to evolve and will become more detailed and specific as more experience is gained with these products and harmonization can be possible.

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  • About the authors and Affiliations

    Author(s) Name:

    R.Suthakaran

    Affiliation(s) Name:

    Department of Pharmaceutical Chemistry and Drug Regulatory Affairs, Vijaya College of Pharmacy, Hayath nagar, R.R.Dist, Hyderabad, Andhra Pradesh, India

     

    *Corresponding author.
    R.Suthakaran
    Department of Pharmaceutical Chemistry and Drug Regulatory Affairs
    Vijaya College of Pharmacy,
    Hayath nagar, R.R.Dist,
    Hyderabad, Andhra Pradesh, India
    E-mail:drsutha2010@gmail.com

    Received on:09-11-2013; Revised on: 17-12-2013; Accepted on:26-12-2013

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    Author:

    R.Suthakaran

    Title:The assessment of current regulatory guidelines for Biosimilars - A Global Scenario
    Journal:Journal of Pharmacy Research
    Vol(issue):8 (January )
    Year:2014
    Page No: (49-52)
  • Experimental Methods Keywords

    Methodology:guidelines
    Research Materials:Biosimilars

Keywords

Biosimilar biologic drug products biosimilarity marketing approval harmonization

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