Cancer is second leading cause of deaths globally which took close to 9.6 Mn lives in 2018. Almost 46% of people died due to cancer were 70 years or older, whereas over 70% of the people died in low-middle income countries.
Biosimilar is a biological medicine similar to already approved Biological Innovator medicine also known as reference medicine. It may not require extensive clinical trials and testing as required in the case of biologics.
In 2019, the North America market for biosimilar was USD xx Billion and it is expected to reach USD yy Billion by 2025. 2015 was the first time when any Biosimilar got approval from US FDA.
Europe is among the global pioneers in approval of Biosimilars. Market Size of Biosimilars market in Europe is USD XX Bn & is growing at a rate of x% y-o-y.
In March 2020, Insulin was officially moved to biologic regulatory framework by US FDA. This coupled with new guidelines on relaxation in comparator clinical trials data may prove to be boon for entry of cheaper Insulin Biosimilars in the US.