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Published on: May 4, 2017
Regulatory considerations in biosimilars: Latin America region
Anurag S Rathore1, Ankita Bhargava1
1Department of Chemical Engineering, DBT Centre of Excellence for Biopharmaceutical Technology, Indian Institute of Technology, Delhi, India.
Abstract:
Development of biotherapeutic products has experienced steady growth over the past three decades. Expiration of patents on many biotherapeutics such as insulin, human growth hormone, and erythropoietin has opened the door for the development of biosimilars. The high cost of biotherapeutics has limited their accessibility, particularly in developing countries. Biosimilars offer the much- needed affordability and hence improved accessibility. Global agencies such as the World Health Organization are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems. This article summarizes the prospects of biosimilars in the Latin American market. Legal framework in various countries is also discussed.
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