Welcome to the Week in Review.
FDA Announces Steps to Expedite Approval of Lower-Cost Biosimilars
The FDA took a significant step in accelerating biosimilar approvals this week, announcing a new draft guidance to cut unnecessary red tape and streamline duplicative clinical trial requirements. The change is designed to speed lower-cost treatments known as biosimilars to market for diseases like cancer, arthritis, and autoimmune conditions, delivering relief to patients who’ve waited too long for more affordable options. It’s a move we’ve long supported: the P4ADNow-endorsed Biosimilar Red Tape Elimination Act, introduced by Senators Lee, Hassan, Paul, and Lujan and Representatives Pfluger and Landsman, would codify the same commonsense reforms. While this is welcomed progress, there’s still an urgent need to address the patent abuses that big drug companies employ to block competition and keep lower-cost alternatives from reaching the market. That’s why we’re pushing for several bipartisan patent reform measures in Congress that would close these loopholes and complement the FDA’s announcement – ensuring faster access to affordable medicines for patients. — [C-SPAN, FDA, Congress, P4ADNow, New York Times, The Hill, Endpoints News, STAT News, Fierce Pharma, BioPharma Dive, Bio Space]
Senate HELP Hearing Highlights Need for Affordable Prescriptions
Amid growing bipartisan pressure to lower drug prices, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing this week on U.S. biotechnology that revealed familiar fault lines. While some lawmakers echoed industry talking points about the IRA’s impact on innovation, others pressed for action to make drugs more affordable. Dr. Aaron Kesselheim of Harvard Medical School and Dr. Reshma Ramachandran of the Yale School of Medicine cut through the noise — underscoring what patients and advocates have long known: innovation is useless if people can’t afford it.
- Dr. Ramachandran: “New biotechnology discoveries will be of no use to my patients or any patients if they’re unable to afford them.”
- Dr. Kesselheim: “There have been no changes in innovation as a result of the Inflation Reduction Act, and in fact, investments have increased in those first few weeks afterward.”
- Sen. Sanders: “One of the issues that must be looked at today is not only innovation, but the cost of medicine in the United States, and in my view, we can no longer tolerate the American people paying by far — not even close — the highest prices in the world for prescription drugs.”
The hearing made clear that while pharma continues to frame affordability as a threat to innovation, experts — and an increasing number of lawmakers on both sides of the aisle — are focused on the real issue: ensuring breakthroughs in medicine actually reach the patients who need them.
Cigna Ends Prescription Drug Rebates — Will Patients Benefit?
Cigna is the latest to promise lower drug prices — but whether patients will actually benefit remains an open question. On Monday, the Cigna Group, which owns pharmacy benefit manager (PBM) Express Scripts, announced plans to eliminate prescription drug rebates across many of its commercial health plans starting in 2027, claiming that the move will lower “monthly prescription drug prices by an average of 30% for those who pay full cost.” HHS Secretary RFK Jr. praised the move, saying it aligned with the administration’s “vision of empowering patients.” But the details matter. Previous efforts to pass rebates directly onto patients have often resulted in raised premiums or produced limited savings for most enrollees, especially those not paying full price for their drugs. In an interview with Bloomberg Radio, Cigna Express Scripts president Adam Kautzner said the company expects to “extract more value out of drug manufacturers” — and Cigna’s stock rose nearly 2% by midday of the announcement. Cigna’s move may grab headlines, but the real test is whether the savings reach patients, or just stay with insurers and manufacturers. — [Axios, Bloomberg, X.com, Bloomberg Radio, Endpoints News, Washington Post, STAT News]
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Patient Advocate Spotlight: Bob Parant
Background: New York resident, living with diabetes for 53 years
Condition: Type 1 Diabetes
Drug: Insulin ($825 per month, before the $35 cap) and Entresto ($765)
In his words: “I am thankful for the insulin that has been developed that I use to manage my disease, but the cost is inhumane. I need insulin to live, but far too often, the high prices of insulin stand in the way of patients accessing this essential drug.”
“The reforms passed in the Inflation Reduction Act make a huge difference in my life. The new $2,000 cap on out-of-pocket costs for my prescriptions, plus the $35 insulin copay caps, mean that I’ll spend much less each year on my drugs. With lower drug costs, I’ll be able to visit my grandchildren more and not worry as much about my retirement funds.”
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