Biosimilars and Follow-on Biologics are copied version of reference biologics which are protected by intellectual rights. We are now reaching the long anticipated period of patent expiration which is the major driving factor of the Biosimilars market. With some $60 billion worth of the pharmaceutical industry’s biggest blockbuster biologics coming off patent in the US and Europe in the next four years, contributing a significant gap to be filled with a more cost-effective follow-on products. This would provide a competitive advantage to local pharmaceutical manufacturers over the global players, undoubtedly that the market for biosimilar and follow-on biologic products is due to burst.

Furthermore, regulations plays a crucial role in sustaining feasibility and equilibrium between the original and biosimilar products. Key markets such as US and Europe are now vigorously regulating the sector, with FDA and EMA now providing guidelines for regulatory approval, biosimilar companies from less established market can now see to differentiate current practices needed to gain approval in new markets.
Another contributing factor to take the biosimilars market to a new heights is the continued rise in chronic diseases among aging populations which continues to drive the need for more cost-effective healthcare in developed countries.

However, some scientific challenges, unanswered questions and uncertainties surrounding biosimilars and follow-on biologics are creating remarkable obstacles for companies to increase uptake in the global market. The only way to success is to organize a cross disciplinary team with expertise in biological products, clinical development, regulatory affairs, and medical practices to watchfully plan a proper development strategy.

A recently released report suggests that the global market will reach $36 billion by the year 2020, up from the estimated $1.3 billion in 2013. High profitability is the attractive aspect that is enticing companies to invest in the biosimilars industry.