Category Archive for "Perspectives"

The increasing demand for medicines and other biologic products paved the way to the development of methods that can speed up its production in order to meet the needs of its consumers. One of which is the utilization of biosimilar product, which is defined by the U.S. Food and Drug Administration (FDA) as ‘a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product’.

The emergence of biosimilars is known to be in accordance with the Patient Protection and Affordable Care Act (Affordable Care Act) signed by US President Barack Obama on March 23, 2010. This law was promulgated in order to establish an expedited licensure pathway for biological products that exhibited no significant difference, in terms of safety and efficacy, with an existing FDA-licensed biological product (U.S. Food and Drug Administration, 2016).

Pharmaceutical companies venturing on the production of biosimilars have envisioned market opportunities and have found some interesting advantages of this undertaking. By the year 2020, biologics with estimated sales of $100 billion will lose its patent protection. Since the development of an original biological product entails a complex process and expensive costs, several companies tend to produce biosimilars, instead. Biosimilars are thought to have greater chances of making it to the market, therefore less risky than branded biologics. Aside from this, investment in biologics is much higher compared to that of biosimilars with relatively lower probability of success. In fact, as of December 2012, it was estimated that the average cost of research and development (R&D) of new drugs may reach $1.9 billion with only 1/10 probability of commercial success after approximately 13.5 years of R&D (Blackstone & Joseph, 2013).

The following will give us an overview of some of the biosimilars which have been available in the market, according to FDA’s Center for Drug Evaluation and Research (U.S. FDA Center for Drug Evaluation and Research , 2016).