The Next Drugs: An Atlantic Policy Briefing on Biosimilars

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/

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.