Biosimilars 101: The Science, Approval Process, and Implications for Your Practice

Since their emergence in the early 1980s, biologic drugs have been increasingly viewed as the future of medicine. Biosimilars are “follow-on” reproductions of these complex molecules. By 2015, more than 30 branded biologics are expected to lose patent exclusivity, while the pool of biosimilars is expected to grow more than 20% per year.
Now that the US Food and Drug Administration (FDA) has authority to approve biosimilars, they are expected to enter the US market within the next 1 to 2 year...