Insights of biosimilars through SWOT analysis

Abstract

Biological drugs, derived from living organisms, have immensely helped millions of patients across the globe. Biosimilars, although are the copies of the existing innovator biological products, cannot be substituted like the generic drugs owing to several differences. The final products in case of biosimilars are not identical as they are prepared from different cell lines by using different production methodologies and purification processes. Due to these differences, several challenges exist for entering into the biosimilar market. Many regulatory guidelines are now available for the approval of biosimilars. This renders an opportunity for healthcare community and industries to develop biosimilars in order to provide cost-effective treatment to the patients suffering from serious and life-threatening disorders. Despite the fact that entry of any biosimilar into the market would offer a competitive price advantage, large controversy exists regarding merits and demerits of biosimilars. In the present Editorial, we have carried out strength, weakness, opportunities and threats analysis of biosimilars so as to assist the readers in having a better understanding with broader perspective of biosimilars