The FDA’s approval of Zarxio, the first biosimilar product authorized for use in the United States, led to a flurry of predictions Friday about billions of dollars in savings and expanded access to treatment for patients. But what exactly are biosimilars, and why are they being hailed in this way?
In order to understand biosimilars, one first has to go back to biologics, which are medical products – like medications, or drug therapies – that are derived from living things or organic material, be they human, animal, bacteria or yeast. Biologics can include vaccines, blood and blood products, and gene and stem cell therapy. Manufacturing biologics is a highly complicated process of turning proteins into medicines; unlike most chemical drugs, biologics involve large and complex molecules. These medications are used to treat serious conditions and illnesses, such as cancer, rheumatoid arthritis or multiple sclerosis.