Biosimilars is a biological product designed to have similar active properties to the one that has been previously licensed and has no clinically significant differences in terms of safety and effectiveness. Biosimilars insulin is a type of biosimilars where it is indistinguishable to the reference insulin product and is already been approved by FDA or licensed. The producers of biosimilars use the similar manufacturing techniques as of the patented product but not likely identical to that used by the patent holder. Due to increasing insulin manufacturers from the developed and developing countries, the patents for insulin formulations had neared expiry or were ended. This created a necessity to seek approvals on biosimilar insulin for the not yet established companies in the highly regulated markets such as Europe and United States.
In 2014, The European Commission (EC) first granted insulin treatment through the biosimilars pathway to Eli Lilly and Company and Boehringer Ingelheim GmbH. Lilly/Boehringer Ingelheim developed a biosimilar insulin called “Insulin glargine” and was the fourth diabetes product which was approved from Lilly-Boehringer Ingelheim Alliance in Europe. Basaglar is the first “biosimilar” insulin product to be approved and launched in U.S. which was developed by the alliance of Lilly/Boehringer Ingelheim.
For More info Click Here.