Biosimilars and the European experience: implications for the United States.

Biologics are medicines derived from a biological source. Their high prices and rapid uptake have raised hopes that with the gradual expiration of patents on the first generations of biologics, the advent of lower-cost follow-on products known as biosimilars will help "bend the cost curve." Although biosimilars have been available since 2006 within the European Union and are expected to save $15-$44 billion by 2020, the Food and Drug Administration (FDA) has yet to finalize the necessary regulatory processes for their approval in the United States. The European experience suggests, however, that once these are in place, the US biosimilar market may well emerge as bimodal: Initially, modestly discounted biosimilars deemed noninterchangeable with the original products will compete to become the initial treatment of choice in new patients. Subsequently, a second market may be anticipated for those products able to meet the FDA's higher standard for "interchangeability." In that market, discounts may be more dramatic.