The high cost of pharmaceuticals, especially Biologics, has been proven as an issue in the battle to control healthcare costs. The Biologics Price Competition and the Innovation Act has put forward the generic competition of Biologics or what is popularly called the Biosimilars. Biosimilars have been available in the European market since 2006, and have recently entered the US market. The Biosimilars had a rough start, as they were not accepted in both the US market and the European market till few years ago, mainly because the term Biosimilar was misused. They were being misinterpreted as the non-trustable version of Biologics, as people believed that biosimilars would not produce the same effect as that of the biologic. The scenario was same for both the regions, including the Asian countries.
Even though the Biosimilar market has grown over time, it is still relatively small. Since the landmark approval of the first biosimilar in Europe in April 2006, there have been approximately 40 biosimilars approved in markets all over the globe. Sandoz’s Zarxio was the first U.S. biosimilar to enter the market, receiving approval in 2015 and entering the market at a 15 percent discount. The emergence of a supportive regulatory approval pathway for biosimilars and patent expiries on major biological products are expected to change this situation. The market is slowly gearing up with marketing authorizations received by Benepali, Flixabi, Erelzi, Amjevita, which has strengthened the biosimilar area and 2017 is expected to see more approvals in this niche.
Biosimilars represent an attractive market opportunity in the pharmaceutical industry. The potential market is expected to grow due to the overall dynamics in the biologics market and the patent expiration of blockbuster candidates. The perspective of the scientific community towards biosimilars has changed from skeptical to rather positive in the last 10 years, probably reflecting the evolution of regulatory guidelines and technological progress. However, physicians, responsible for the prescription of drugs, are still rather skeptical about biosimilars and need to be better informed. In order to increase the currently low market penetration of biosimilars, the companies are working towards involving themselves in the doctor-patient dynamics to increase use of their biosimilar candidates. Looking at the market scenario now, the biosimilars industry is expected to step out of its infancy stage and finally enter the growth phase.
Devadrita Dey Sarkar
Business Development Executive