Biosimilars | Association for Accessible Medicines
AAM All Access Podcast - Dan Leonard speaks with Mary Beth Powers, President and CEO of CMMB.

Biosimilars

GDUFA and BsUFA User Fees

What are GDUFA and BsUFA user fees? Watch this this video to learn more about how the Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Act (BsUFA) help to get more generic and biosimilar medicines to patients more quickly. Over ten years, the generic and biosimilar industry has provided the FDA over $4 billion for review and approval of lower-cost treatments for America’s patients. The result is more than $2 trillion in savings to patients and a dramatic increase in patient access to life-saving treatments.

 

HHS OIG Report Demonstrates Need for Changes to Part D to Increase Biosimilar Use

Biosimilars provide more options for care at a lower cost for patients, but due to Medicare’s perverse incentives, many PBMs and health plans have been slow to prioritize biosimilars, leavings savings on the table. Last week, the HHS Inspector General (OIG) released an important analysis that drives home just how poorly Medicare plans are doing when it comes to making FDA-approved biosimilars available to America’s seniors.

Greg is Treating His Ulcerative Colitis, and Enjoying a Slice or Two

Greg, 37, of Los Angeles, Cal., spends most of his time hiking, running and lifting weights, but his greatest passion in life is pizza. Not long ago, he made a bet with his wife that he could eat pizza and nothing but pizza for 45 days. As if that weren’t unusual enough, you should know that Greg has a history of ulcerative colitis.

Steroids were not controlling his condition, so his gastroenterologist put him on a biologic medication. After a while, his insurance plan recommended switching to a biosimilar—a safe, effective alternative to a brand-name biologic.

Eileen's Story – Savings from Biosimilar Medicines

“I’ve been fighting Crohn’s disease with a biologic medication for as long as I can remember. When I turned 26, I switched health care plans, and the biologic that I had been taking for years wasn’t covered anymore, but my doctor knew of a biosimilar that would be. So we made the change, and now I don’t pay anything for my infusions. I hope that others can have the same access and that more biosimilars will become available on insurance plans in the future. I can’t imagine not having access.” — Eileen, 28, New York, NY.

Greg's Story – Savings from Biosimilar Medicines

Steroids were not controlling Greg’s ulcerative colitis, so his gastroenterologist put him on a biologic medication. After a while, his insurance plan recommended switching to a biosimilar—a safe, effective alternative to a brand-name biologic. “My doctor was on board,” recalls Greg, a weight lifter and pizza fanatic. “I trust my doctor, so I switched to the biosimilar and it’s been smooth sailing ever since.”

Savings from biosimilars for patients like Greg totaled $8 billion in 2020 and are projected to save $133 billion over the next five years.

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