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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 prequalificatio