The promise of biosimilars has captured the attention of the medical community. These drugs are described as the next wave in medicine, promising new treatments to help more Americans cope with serious diseases. But the nature of biosimilars complicates their path to market. As complex large molecule drugs, biosimilars are subject to a relatively new statutory regime, presenting novel regulatory issues. And there are a growing number of biosimilar applications on the horizon.
The Atlantic gathered key stakeholders to examine the emerging world of biosimilars and their regulatory framework in the United States. How does the Food and Drug Administration implement the biosimilar approval pathway? Do biosimilar drugs require the same clinical trials as the biologics on which they are modeled? How will the process impact access and affordability, and what does it mean for innovation?
For more information and for full video recaps of the event, please visit The Atlantic at https://www.theatlantic.com/live/events/biosimilars-politics-and-policy/2016/