The global biosimilars market was valued at $2,552.0 million in 2014 and is expected to reach $26,551.3 million by 2020, supported by a CAGR of 49.1% during the forecast period 2015 to 2020. Biosimilars or follow-on-biologics are the “copied” and licensed versions of those reference biologics that have undergone patent expiration. Biosimilars development and validation with reference biologics is a crucial aspect of the overall development process. Regulations for biosimilars play a vital role in maintaining the viability and balance between original and biosimilars products. Various regulatory authorities such as EMA and FDA actively regulate the biosimilars commercialization and development.