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

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...
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Biosimilar uptake is increasing and so are health savings

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...
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PDUFA and BsUFA reauthorizations are wins for patients

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

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

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...
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Ensuring timely reauthorization of PDUFA and BsUFA

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

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

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...
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The importance of timely PDUFA and BsUFA reauthorization

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

Last week, the U.S. Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III.
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