Towards the Era of Biologics and Biosimilars, a Case Of Insulin

Abstract

Recombinant human insulin is the first protein therapeutic produced by recombinant DNA technology.  Currently, many patents of insulin analogs start to expire.  The intended-copy recombinant human insulins manufactured from various manufacturers around the world have entered the market in Thailand, whereas the regulatory standard in medicine registration varies widely between countries.  Therefore, the basic concept on protein therapeutics, biosimilars and insulin quality considerations will be very useful for physicians, pharmacists, healthcare professionals to help them evaluate and select high quality recombinant human insulins and biological products for hospital formulary.