Welcome to the Week in Review.
New MFN Deals Expected This Month
More most-favored-nation (MFN) drug pricing deals are expected this month, according to CMS Administrator Dr. Oz. Since the administration sent letters to 17 pharmaceutical companies in July demanding adherence to MFN pricing, only five — Pfizer, AstraZeneca, EMD Serono, Eli Lilly, and Novo Nordisk — have announced agreements. The Trump administration has used the threat of pharmaceutical tariffs to bring drugmakers to the table, but those tariffs have repeatedly been delayed. Months after the initial September deadline, the slow pace of new deals highlights the limits of voluntary, company-by-company agreements in securing broad price reductions. Despite the administration’s aggressive posture, most manufacturers have yet to engage — suggesting that without structural reform or enforcement mechanisms, pharma can continue to delay meaningful concessions while appearing cooperative. — [Washington Post, White House, Endpoints News, Truth Social, Reuters]
More Work Needed to Deliver Low-Cost Biosimilars
The FDA’s new draft guidance to accelerate biosimilar approvals is a promising step toward lowering drug costs, but experts say its potential impact is limited without broader reforms. The proposal, supported by P4AD, would remove unnecessary human trials, known as interchangeability studies, when advanced testing already shows that a biosimilar works the same as the brand-name drug and would make it easier for doctors and pharmacists to substitute lower-cost biosimilars, much like generic drugs. Still, barriers remain. Patent thickets, pay-for-delay agreements, and PBM practices continue to block or slow biosimilar entry, even years after approval. Biologics make up more than half of U.S. prescription drug spending, with biosimilars accounting for less than 20% of the market share. Biosimilars have generated $56 billion in savings since 2015, and expanding their use would unlock further savings for patients and for taxpayers. In interviews, experts noted that fixing these problems is critical to ensuring the FDA’s action translates into real affordability for patients. P4AD has been pushing for comprehensive bipartisan reform measures that would help close these loopholes and ensure faster access to affordable medicines for patients. — [Bloomberg Law, P4AD]
Patient Advocate Spotlight: Kevin Baker
Background: 22-year-old college student from Idaho living with Crohn’s disease
Drug: Rinvoq ($6,431)
In the words of his wife Janet:“I’ve lived with Crohn’s disease since I was 11. My current medication, Rinvoq, has a list price of $6,431, and past treatments like Remicade, Humira, and Stelara range from $1,100 to $14,000 per month before insurance. I believe life-saving medicine is a human right.”
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