Biosimilars Handbook

Innovation & Access

Advancements in the research and development of biologic medicines have pushed the frontiers of science to bring lifesaving and life-altering treatments to patients suffering with deadly diseases. For example, thanks to biologic research, remarkable progress has been made in treating many types of cancers. Biologic therapies have also helped patients make great strides in managing chronic diseases like multiple sclerosis, diabetes, rheumatoid arthritis, and Crohn’s disease.

Given the amount of research, it is no surprise that biologic medicines now account for more than a quarter of annual Center for Drug Evaluation and Research (CDER) drug approvals in the United States, compared with only 13 percent from 2004-2008. In 2015, seven of the 10 top-selling medicines were biologics. This is a sharp increase from just a decade ago when only one biologic was on the top 10 list of drugs prescribed in the United States. Moreover, there are 1,000 new biologics in development, targeting more than 100 diseases. Notably, the global biologics market totaled $200 billion in 2013, and is expected to soar to $387 billion by the end of 2019, at a compound annual growth rate of 10.6 percent.

Biologic medicines are costly. While only 2 percent of the U.S. population uses biological drugs, biologics account for 40 percent of prescription drug spending in the U.S. Originator brand biologics can cost the health care system as much as several hundred thousand dollars per patient, per year. Research shows that the average daily cost of a biologic product is approximately 22 times greater than the daily cost for a traditional drug, thus making safe and effective alternatives an imperative for patients. Data also show that biologic prices keep rising. Between 2011 and 2012, prices for specialty drugs—drugs including biologics—increased by 12.9 percent.

Fortunately, more affordable options for many patients who rely on biologic treatments are beginning to enter the market: biosimilars. The approval of biosimilar and interchangeable biologic products will generate competition that lowers costs for patients, providers and the overall health care system.

Some estimates suggest that during the first 10 years of biosimilar availability, consumers could save as much as $250 billion. Biosimilars and interchangeable biologic products are intended to create the market dynamics needed to lower the cost of biologics and provide patients with much-needed access to lifesaving treatments. Furthermore, biosimilars drive competition to treatment categories where there are few options, if any. This competition stimulates further investment and innovation in health care.

The availability of more affordable biologic medicines (biosimilars) translates into enormous savings for patients, taxpayers, insurers, providers, and state and federal governments.