Takeaways from discussions on the Trump administration’s drug price controls with leaders at last week’s Association for Accessible Medicines’ Access 2026 conference
With all of the chatter on the Web, including in BR&R, on the policy and legislative actions that affect biosimilars, we were eager to hear from some very smart people on the direct-to-patient (DTP) channel as a whole, including TrumpRx; most favored nation (MFN) and Medicare maximum fair price (MFP), among other issues. Although the Blizzard of 2026 prevented us from basking in the sun in Miami, the AAM provided video recordings of the sessions for those who were left in a snow bank. In a two-part post, we’ll relate some of the takeaways from the most compelling discussions.
TrumpRx and DTP: Much Ado About not Too Much?
Brian Reid, Principal, Reid Strategic, and Senior Fellow, Tufts Center for the Evaluation of Value and Risk in Health, reminded the AAM attendees that “direct-to-patient sales were there before TrumpRx.” He believes that perhaps the weight-loss market is viable on these platforms.
However, in terms of biosimilars and generics, “20 of the 43 drugs listed on TrumpRx have generic alternatives. What are we really talking about here? With generics, you can get a 95% discount,” which is far better than with the TrumpRx price on the brand. Mr. Reid pointed out that “out of a million scripts for pantoprazole written, only 400 are written for the brand Protonix; the rest are generics.”
Mr. Reid mentioned that “Pfizer’s adalimumab biosimilar (Abrilada) is listed on TrumpRx, and it’s the lowest priced adalimumab out there. I know we’re not talking about high-dose or low-dose concentration. It may be a missed opportunity to talk about biosimilars here, beyond the GLP-1s.”
MFN Pricing: Political or Economic Benefit?
Scott Gottlieb, MD, former FDA Commissioner, raised an important MFN pricing issue for biosimilar and originator manufacturers alike: The expected reaction by pharmaceutical manufacturers for a product affected by MFN pricing will be to raise prices in the countries included in the international index on which MFN pricing is based. This then does not directly affect US sales, but it may hinder launches in those countries. Dr. Gottlieb said, “Some launches will be delayed in Europe as a result—there will be harder negotiations for acceptable prices [such as the UK’s NICE]. This will open the market for potential Chinese companies who can launch drugs at lower costs than we can.”
Mr. Reid emphasized that in DC right now, “the talk is about affordability. Why aren’t we getting the policy solutions we need? It’s acknowledged that generics and biosimilars are part of the solution. Instead, lowering drug prices by fiat seems simple, but ignores the [downstream] effects. Everyone seems in favor of price controls, but what happened to market competition,” engendered by biosimilars?
He believes MFN pricing is creating political benefit for the administration but not clear economic benefit. “If the goal is to lower drug prices, it’s not clear that this has happened. It’s a lot easier to threaten foreign countries than to get drug prices lower in the US. People in other countries are very freaked out.”
Sixty Days into MFP Pricing
In January 2026, the initial negotiated Medicare MFP prices were implemented. Within this group of drugs, Stelara stood out. Biosimilar competition began a year ago. Mr. Reid commented that overall, the “Stelara biosimilar market is incredibly competitive, playing out exactly as any economist would want.”
Interfering in this free-market scenario though is the Inflation Reduction Act mandate that if an originator manufacturer agreed to an MFP-negotiated price, that targeted drug cannot be excluded from Medicare formularies. Mr. Reid stated that as a result, “Stelara is carried on every Medicare part D formulary until 2027, which is a huge disservice to consumers and payers. This is a pivotal year for the ustekinumab market, and who wants to lose this pivotal year of that ability for biosimilars to compete against a full-WAC priced product (not artificially lowered). Now we’re living it.”
He pointed out that ustekinumab biosimilars are priced significantly lower than the MFP-negotiated amount. “Taxpayers lost because we didn’t rely on the biosimilar competition solely? Maybe by the time Xolair is up for MFP implementation, CMS will learn its lesson and pull it back,” he said. “The first round of drugs with MFP price controls are on the cusp of generic use. How does this play in with the IRA? How soon should CMS pull drugs out of the MFP program to allow full generic competition in a free market, not an artificially depressed price market?”
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.