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.
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Biosimilar insulin proved to have an effective treatment for patients suffering from diabetes mellitus by reducing the cost for the treatment. There are some companies who have developed devices which allow the safe and less painful delivery of biosimilar insulin thus making the device a market differentiator even though it’s chemically equivalent to the branded product. Many companies in the emerging economies have started developing biosimilar insulin due to the favorable regulatory requirements as compared to the companies in developed countries where their stringent regulatory requirements. As the regulatory requirements for the approval process of biosimilars are considerably higher than those required for the generic drugs and entail the comprehensive analysis for each of its characteristics.
Biosimilars have increased the opportunities in healthcare services and have decreased the expenditures creating a significant competition between the companies manufacturing branded products and biosimilars. Globally, the major factors responsible for surging the demand for biosimilars insulin in the market are increase in diagnosed and undiagnosed diabetes, patent expiry for insulin, growing population. Diabetes is considered to be one of the fastest growing disease and attribute to 3 million deaths annually, and has become a pandemic. Increasing poverty level in developing countries has created a pressure on the healthcare industry to develop cost effective products and treatment options especially for diabetes patients. The only aspects which can affect the biosimilars market are safety and efficacy of new biosimilars also the stringent regulatory bodies leading to delayed approvals.
According to the Biosimilars Pipeline Database, there are total 1,357 product entries for biobetters and biosimilars constitute 737 of them (March, 2016). Among the top targeted reference products, insulin and analogs constitute 51 and the companies producing it include Biocon, Mylan N.V., Sanofi, Novo Nordisk and others. Sanofi, a multinational pharmaceutical company is also developing LixiLan, a mix of basal insulin with GLP-1 which is directed to treat for type 2 diabetes. Eli Lilly and Company, a U.S. based company is currently running Phase III clinical trials for a non-insulin drug Empagliflozin (BI10773) targeting the treatment for type 1 diabetes.
The new trend in the market is developing ultra-rapid acting insulins to replace Humalog and Novolog (patents expired) which is important for pump users and disorder related to real-time artificial pancreas. There are new attempts made by companies to create oral insulin such as ingestible capsules for better drug delivery. Most of the biosimilars have reached Phase III and are soon to get approved by the respective regulatory bodies and will reach the market with cheaper prices as compared to the branded products.
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Various multinationals are forming alliances and partnerships to develop biosimilar insulin such as Eli Lilly and Company and Boehringer Ingelheim Gmb, Biocon Limited and Pfizer Inc., Mylan N.V. and Momenta Pharmaceuticals.
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