Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this diseas...Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this disease because of modified food habits and lifestyle changes that are alien to the physiological system. The control of blood glucose level would be the prime focus of all the therapeutic targets, which is achieved through drugs, modified lifestyle, and paleo-based diets. To find a solution to these problems, earlier humans have revolutionized the science with the discovery of insulin from the porcine pancreatic crude extract. Later, developments have been made with artificial recombinant insulin and even insulin analogs that would mimic the physiological basal insulin in controlling the blood sugar levels. Various factors such as cost and logistics for quality delivery to the end-user at various corners of the world have impeded the reach of the original product. Hence, biosimilar insulins that are original insulin analogs were designed to execute similar physiological functions. In the current situation, the use of biosimilars has been approved in various clinical conditions that are very promising in its functions. In the present review, the various developmental phases of biosimilar preparations and the regulations enforced ensuring a quality product in the market through the Food and Drug Administration and the European Medicines Agency have been discussed.展开更多
基金supported by the KU Research Professor Program of Konkuk UniversitySeoulSouth Korea
文摘Diabetes mellitus, an endocrine disorder, has a wider reach among most of the world population. The incidence of diabetes is high not only among adults but wider-age groups are also becoming susceptible to this disease because of modified food habits and lifestyle changes that are alien to the physiological system. The control of blood glucose level would be the prime focus of all the therapeutic targets, which is achieved through drugs, modified lifestyle, and paleo-based diets. To find a solution to these problems, earlier humans have revolutionized the science with the discovery of insulin from the porcine pancreatic crude extract. Later, developments have been made with artificial recombinant insulin and even insulin analogs that would mimic the physiological basal insulin in controlling the blood sugar levels. Various factors such as cost and logistics for quality delivery to the end-user at various corners of the world have impeded the reach of the original product. Hence, biosimilar insulins that are original insulin analogs were designed to execute similar physiological functions. In the current situation, the use of biosimilars has been approved in various clinical conditions that are very promising in its functions. In the present review, the various developmental phases of biosimilar preparations and the regulations enforced ensuring a quality product in the market through the Food and Drug Administration and the European Medicines Agency have been discussed.
