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The 340B program is interfering with the U.S. biosimilars market and impacting patient costs

By Nicole Longo  |    November 21, 2022
Research has shown that 340B hospitals are more likely to prescribe more expensive medicines and significantly mark up the price of medicines. For example, 340B hospitals received nearly five times...   Read More

Biosimilar uptake is increasing and so are health savings

By Jocelyn Ulrich  |    October 17, 2022
There has been a lot of talk recently about the biosimilars marketplace and what role biosimilars play in reducing health care costs. We’re here to set the record straight about how these medicines...   Read More

PDUFA and BsUFA reauthorizations are wins for patients

By Stephen J. Ubl  |    October 5, 2022
America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription...   Read More

Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

By Andrew Powaleny  |    September 12, 2022
As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug...   Read More

New research shows competition driven by biosimilars helps control costs in Part B

By Gabby Migliara  |    July 19, 2022
Discussions about spending in Medicare Part B, including a recent report from the Medicare Payment Advisory Commission, or MedPAC, too often overlook how competition between medicines drives down the...   Read More

Ensuring timely reauthorization of PDUFA and BsUFA

By Matthew Norawong  |    May 11, 2022
Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the...   Read More

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

By Andrew Powaleny  |    March 17, 2022
Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing...   Read More

Part B 101: Three charts show the program helps control costs for health care system and enrollees

By Nicole Longo  |    February 18, 2022
Medicare Part B covers a wide range of health care services, including physician office visits, hospital outpatient care and medical equipment. It also covers medicines that are usually administered...   Read More

The importance of timely PDUFA and BsUFA reauthorization

By Lucy Vereshchagina  |    February 3, 2022
Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and...   Read More

Biosimilar User Fee Act (III) Performance Goals Letter will help increase options for patients and promote competition

By Richard Moscicki, M.D.  |    September 28, 2021
Last week, the U.S. Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III.   Read More

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