The Opportunities and Challenges Involved in Registration of Similar Biotherapeutic Products in Emerging Countries
Journal Title: International Journal of Research in Pharmacy and Science - Year 2013, Vol 3, Issue 3
Abstract
Although global biosimilars market looks attractive and continue to grow, the regulatory and operational hurdles remain in emerging regions. Many emerging nations are establishing biosimilars regulatory pathways, giving sponsors opportunities to select research sites strategically to optimize overall development timelines and achieve registration goals. Implementing studies across countries with varying regula¬tions involves layers of complexity, but these challenges can be overcome with in-depth knowledge of each local environment and early strategic planning.Due to the influence of EMA and U.S. FDA regulatory precedents, such a move would likely lead to harmo¬nization globally in the long term. In fact, guidelines from several countries in emerging regions, notably Singapore, Malaysia, India, Saudi Arabia and Egypt (as well as in Canada and Australia, as they largely fol¬low EMA guidance), already provide a certain degree of comparable harmonization in requirements and even include flexibility regarding data generated with reference products registered outside their jurisdiction if such products are marketed in key reference markets and/or meet certain requirements.WHO’s role in building the technical expertise in NRAs worldwide is recognized as an important contribution towards better regulation of biotherapeutics as a whole. One of the specific tasks in coming years will be the provision of appropriate scientific principles for the evaluation of biotherapeutics as standalone products.
Authors and Affiliations
D Navaneethaselvan , S. B. Puranik
Keywords
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