FDA Panel Recommends Approval for First 'Biosimilar' Drug

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee has recommended that a new drug be approved as the first “biosimilar” generic alternative to an existing biologic, which is a drug that has been produced by living cells.    

The Novartis cancer drug would be the first approved under the Biologics Price Competition and Innovation Act of 2009, which passed as part of the 2010 Patient Protection and Affordable Care Act. The law created a pathway to market for biological products that prove to be highly similar—biosimilar—to an already approved FDA biologic drug. 

While cheaper, generic versions of brand-name chemical drugs have long been available to patients, drug companies have been unable to develop exact copies of biologics. Introducing biosimilars, which are not identical to the original biological product but produce comparable results, has the potential to produce cost savings and help more patients afford necessary and often lifesaving treatments. Pew’s specialty drugs project is exploring policies that could reap such savings and help patients afford the care they need.  

The next few biosimilars [getting approved] will give us a much better sense for how this market is going to pan out and how much savings there could be for the health system,” Rand Corp. researcher Andrew Mulcahy told Modern Healthcare. In fact, Mulcahy estimated that biosimilars could save as much as $44 billion over the next 10 years.  

Spotlight on Mental Health

Composite image of modern city network communication concept

Learn the Basics of Broadband from Our Limited Series

Sign up for our four-week email course on Broadband Basics

Quick View

How does broadband internet reach our homes, phones, and tablets? What kind of infrastructure connects us all together? What are the major barriers to broadband access for American communities?

Pills illustration
Pills illustration

What Is Antibiotic Resistance—and How Can We Fight It?

Sign up for our four-week email series The Race Against Resistance.

Quick View

Antibiotic-resistant bacteria, also known as “superbugs,” are a major threat to modern medicine. But how does resistance work, and what can we do to slow the spread? Read personal stories, expert accounts, and more for the answers to those questions in our four-week email series: Slowing Superbugs.

Explore Pew’s new and improved
Fiscal 50 interactive

Your state's stats are more accessible than ever with our new and improved Fiscal 50 interactive:

  • Maps, trends, and customizable charts
  • 50-state rankings
  • Analysis of what it all means
  • Shareable graphics and downloadable data
  • Proven fiscal policy strategies

Explore

Welcome to the new Fiscal 50

Key changes include:

  • State pages that help you keep track of trends in your home state and provide national and regional context.
  • Interactive indicator pages with highly customizable and shareable data visualizations.
  • A Budget Threads feature that offers Pew’s read on the latest state fiscal news.

Learn more about the new and improved Fiscal 50.