Monoclonal Antibodies are one of the most evolving and targeted drugs which are being used to treat many diseases like cancers, autoimmune diseases, arthritis, Psoriasis etc. Generics or Innovator molecule of Monoclonal Antibodies are very expensive and some are on their verge of expiry, therefore Evolution of Biosimilars is an urgent need of the hour. Biosimilars are affordable and they are very similar to the innovator molecule when it comes to their structure and function. After the successful Manufacturing of Biosimilar its Approval for the Market is of a great concern. Therefore European Medicinal Agency (EMA) has provided with certain Guidelines for the smooth flowing of Biosimilars in the market. Regulation of Biosimilars in India is concerned by many competent authorities which are interlinked with each other. The above mentioned points have been discussed in this review paper.