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 years. This supplement is intended to increase your understanding of the biosimilar development and approval process, the interchangeability of biosimilars with reference products, and the steps required to evaluate these new products for addition to formularies.
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 years. This supplement is intended to increase your understanding of the biosimilar development and approval process, the interchangeability of biosimilars with reference products, and the steps required to evaluate these new products for addition to formularies.
