The economic implications of biosimilars.

Between 2013 and 2014, spending on specialty drugs, including biologics, increased 32.4%, while spending on small-molecule drugs increased just 6.8%. By 2016, 8 of the 10 top-selling drugs are expected to be biologics. While many biologics will be going off patent, there will likely be multiple prospective manufacturers of biosimilars, and a growing emphasis on regulatory guidelines to ensure their efficacy and safety, in the very near future. A strong factor and assumption surrounding biosimilar development and use is the potential for healthcare cost savings; the introduction of biosimilars is expected to reduce drug costs, although to a lesser degree than seen with small-molecule generic drugs. Managed care clinicians and providers must carefully consider the economic implications and potential cost-effectiveness of uptake of biosimilars for therapy in clinical practice.