Biosimilars in the US : Current and future landscape
Considering the volume of currently available biosimilars and the extensive biosimilar pipeline , there is an urgent need to address the challenges experienced by the United States ’ health care system in fully implementing these agents into clinical practice
Ashley Glode PharmD BCOP University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences , University of Colorado Anschutz Medical Campus , Aurora , CO , USA
Megan May PharmD BCOP Baptist Health Lexington , Lexington , KY , USA
In the US , it is estimated that the addition of biosimilars will reduce direct spending on biologic drugs by $ 54 billion between 2017 and 2026 , or 2.8 % of total biologic spending over the same period . 1 The first biosimilar was approved in the US in March 2015 . 2 At the time of writing of this handbook , the US Food and Drug Administration ( FDA ) has approved 28 biosimilar products , with 17 launched to market . Table 1 shows the current biosimilar landscape in the US .
The future There are just over 1000 biosimilar products in the pipeline , and there has been a 27 % increase in annual growth rates for the biosimilar pipeline since 2012 . 3 Considering the volume of currently available biosimilars and the extensive biosimilar pipeline , there is an urgent need to address the challenges experienced by the US ’ s health care system in fully implementing these agents into clinical practice . The potential cost savings associated with biosimilars will be dependent upon overcoming several obstacles including provider acceptance , patient acceptance , limited availability , interchangeability , and extrapolation . Uptake of biosimilars in the US has not been as expected due to various barriers , some of which are discussed here and also later in this handbook .
Some challenges in widespread adoption Provider acceptance Multiple surveys have revealed that providers continue to have inadequate understanding surrounding biosimilar products in regards to
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