Deeper Views on TrumpRx (the Direct-to-Patient Channel), MFN and MFP, and Biosimilars

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.

Will National PBM Reform Whither Away the Private-Label Channel?

National PBM reform does not address private labeling by PBMs and their subsidiaries directly, but it does imply that PBM private labels will not hold up over the long term.

Since the announcement of the Federal Trade Commission (FTC) and Express Scripts (ESI) settlement, there has been some speculation regarding the effect of the settlement and national PBM reform overall on the potential growth of the private-label biosimilar channel. Whereas neither the national PBM reform provisions of the Consolidated Appropriations Act (CAA) nor the FTC settlement directly addresses private labeling, you could make the argument that this relatively new revenue channel will be negatively affected.

Spread Pricing Before or After Reaching the Pharmacy

Will national PBM reform overall on the potential growth of the private-label biosimilar channel.

The spread-pricing provisions of the CAA address spread pricing inside the pharmacy but not outside of a pharmacy. That is, a PBM’s distributor, like Cordavis, may purchase the unbranded biosimilar from a manufacturer, like Sandoz, at one price, and relabel it and resell it at a higher price. This is not subject to national PBM reform: Like a drug manufacturer at launch, the distributor can name a list price for its relabeled drug.

A PBM’s Fiduciary Responsibility and Conflict of Interest

The strongest, significant barrier to the private labeling status quo is the fiduciary responsibility imposed on PBMs. A PBM-owned private-label distributor creates a conflict of interest that is hard to reconcile.

Although a PBM’s private-label biosimilar may be amongst the least-expensive drugs available, but for a self-insured employer client, for instance, why would you tolerate this incentive, which allows a PBM to earn more money off the backs of your covered workers?

The PBM’s transparency and reporting mandates would seem to ensure that a potential conflict-of-interest situation is disclosed to its clients. Drug unit sales or at least biosimilar market share must be reported on a regular basis.

Thus, the PBM will have to justify its coverage preference for the private-label brand(s). Again, if pricing of that private-label brand is amongst the best deals around, that might be justification enough.

Take into consideration the costs of a private-label product: A share of the profits must go to the original biosimilar manufacturer as part of this relabeling arrangement. The profits must also pay for any other costs related to the relabeling of the product. This also does not consider any royalties that the biosimilar manufacturer may still be paying to the reference drug maker under any patent or launch settlement. As a result, the private-label product is unlikely to be the least expensive (by net price) biosimilar in a drug category. This is definitely not the case with Quallent’s products, which are more mid-WAC than low-WAC.

Rebate Revenues and the Gap That Must Be Filled

The question thus remains whether the private-label channel will continue to grow in influence or withers away as a result of PBM reform. The mandates for rebate pass-throughs will leave a sizable hole in PBM revenue. As national pressure has ratcheted up the urgency for rebate transparency, the PBMs have been working to shrink their dependence on rebate revenues. This has been achieved mostly by increasing administration and service fees. For the big 3 PBMs, this meant raising new revenues through private labeling. Therefore, PBMs will no doubt be reluctant to drop this relatively new, significant revenue source. It may take several years before the provisions of national PBM reform truly affect the private-label channel. For the biosimilar industry, these are extremely important considerations, as private labeling has, depending on the company and drug, increased and decreased biosimilar market access. For drug categories with heavy competition, every biosimilar company worries about making a private-label deal and the implications for failing to make one.

It should also be noted that private labeling has just entered the realm drugs covered under the medical benefit (e.g., McKesson’s pegfilgrastim private label). The implications of this development in the race for Keytruda and Opdivo biosimilars cannot be overemphasized.

Overall, national PBM reform is a very good thing for the biosimilar industry. If private labels are a casualty of this trend, you won’t find much sympathy on the biosimilar side of the fence.

This article was written by our Director of Content, Stanton Mehr. Stan is 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.

Navigating Biosimilar Substitution

This guest commentary is written by Robert Goria, Chief Trade Strategy Officer, CarePartners Pharmacy. The article addresses a practical approach to navigating biosimilar substitution, as we may soon be seeing significant change in the meaning of interchangeability for biosimilars.

The US biologics market is undergoing a quiet but consequential shift. Years after the Biologics Price Competition and Innovation Act created a pathway for biosimilars, regulators and payers are now expanding how these products are distributed, particularly through pharmacy-level substitutions. Although improving access and lowering costs are worthy goals, policies that enable biosimilar substitution without physician involvement raise important concerns about continuity of care, transparency, and patient trust.

Today, federal and state frameworks require a biosimilar to receive an FDA “interchangeable” designation before a pharmacist may substitute it without prescriber consent. However, recent signals from the Centers for Medicare & Medicaid Services suggest a broader practice may emerge, allowing Part D plans to substitute even non-interchangeable biosimilars mid-year for formulary management. In many instances, this practice already occurs when payer policies or PBM’s force a switch among biosimilars or between reference drugs and biosimilars.

Multiple formulary-based changes, especially when tied to payer contracting cycles rather than clinical decision making, risk disrupting care regimens, confusing patients and physicians and serve to erode trust between patients and their providers. Patients trust that clinical decisions will be made by a trusted physician, not by non-transparent formulary updates.

Supporters of pharmacy-driven biosimilar substitution point to faster adoption and cost savings, noting that pharmacy conversions outpace physician prescribed biosimilars. However, biologics are not small-molecule generics. They are complex therapies with immunogenic and clinical nuances. Although FDA-approved biosimilars are deemed safe and effective, many clinicians remain concerned about repeated switching, therapeutic continuity, and patient perception, particularly the potential for “nocebo” effects. Nocebo effect can be defined as “a negative response or harmful effect that occurs because a person expects an adverse outcome, even when the treatment or substance they receive is inactive. It is the opposite of the placebo effect, instead of improving symptoms through expectation, symptoms worsen because of negative expectations.”

Paramount to the topic of interchangeability is the issue of the physician–patient relationship. Patients expect treatment decisions to be made by clinicians who know their history, not by silent formulary changes. Substitution without prescriber awareness can create confusion and erode trust.

There is a practical middle ground. First, real-time prescriber notification should be a baseline requirement. When a biosimilar substitution occurs, interchangeable or otherwise, an automated alert through electronic prescribing systems should notify the clinician immediately. This ensures accurate medication records and appropriate follow-up.

Second, patient education at the point of dispensing must be strengthened. Patients deserve clear, plain-language explanations about what is being substituted, why it is safe, and how it supports their care. Although many states require some form of notification, standards vary widely. A federal baseline would ensure consistent patient protection.

Specialty pharmacies can play a critical role here. Given their close engagement with patients using complex therapies, specialty pharmacists are uniquely positioned to educate patients, coordinate with clinicians, and reinforce that biosimilar switches are clinically sound, not arbitrary cost decisions.

Biosimilars hold real promise, but their success depends on trust built through communication. As substitution policies evolve, transparency, notification, and patient-centered education must be built into the system. Cost savings should never come at the expense of clinical continuity or patient confidence, which are the foundation of good medicine.

This article was written by Robert Goria, Chief Trade Strategy Officer at CarePartners Pharmacy, a national specialty infusion pharmacy focused on niche therapies and markets.

The Biosimilar on TrumpRx: Pfizer Offering Further Discounts on Abrilada

TrumpRx unveiled the first 43 products listed as available through this direct-to-consumer (DTC) clearinghouse site, and one biosimilar is offered, at a discount of more than $300 per dose.

Pfizer’s Abrilada is being offered through TrumpRx at a price of $207.60 per 40 mg/0.8 mL prefilled pen. The prefilled syringe version is $415.20 (for a 2 pack). This represents a 60% discount off its present low-WAC price of $519, and is 46% below the lowest recorded low-WAC price of any of the adalimumab biosimilars available (Idacio), as reported by the Samsung Bioepis Biosimilar Market Report.

Pfizer’s Abrilada is only available in one low-concentration adalimumab formula, whereas the majority of the competitive biosimilars have the widely used high-concentration formulation. Furthermore, the TrumpRx site only lists one dosage of its prefilled syringe and pen, whereas the drug is available in other doses via the prefilled syringe. Abrilada does utilize the preferred citrate-free formula.

Based on IQVIA data utilized by Samsung Bioepis, Pfizer’s share of the adalimumab market is less than 2%, and thus the company may believe that it had little to lose with this DTC pricing. Cash-paying patients will comprise a very narrow share of adalimumab purchases.

With the Federal Trade Commission (FTC) settlement with Express Scripts, reported this week, the FTC ordered the PBM to make TrumpRx accessible to insured patients as well. Since insured patients (outside of an initial deductible) will generally pay considerably less than $200 per dose out-of-pocket, and to this date a cash DTC transaction does not contribute to the patient’s deductible, this will likely remain an access point for uninsured patients who can afford the DTC price.

TrumpRx will likely add other biosimilars or biologics to its list of available products in the future. However, until the mechanism is worked out to include these DTC transactions into the plan’s or PBM’s electronic systems, this access channel will remain limited for biologic agents.

The FTC–ESI Settlement: Net Price Rules at the Pharmacy Counter

Perhaps the greatest effect of yesterday’s announced Federal Trade Commission (FTC) settlement with Express Scripts is its mandate on consumer exposure to net prices at the pharmacy counter as opposed to the inflated list prices of insulin products. But the implications go far beyond insulin. The settlement may contribute to the demise of high wholesale acquisition cost (WAC) pricing.

The FTC stated that Express Scripts would, as part of the agreement, now list preferred drugs under their low-WAC, not high-WAC, prices on standard formularies. In addition, Express Scripts will interface with the federal government’s TrumpRx site to allow the PBM’s members access to direct-to-consumer pricing platforms within its standard pharmacy benefit design.

Affecting Insulin and Beyond

All Big 3 PBMs were sued by the FTC over alleged insulin price fixing. To date, only Express Scripts has reached an agreement with the FTC. The settlement reached by the FTC may cause much consternation and uncertainty with big 3 leadership and investors, but it is unquestionably a step in the right direction.

When patients’ out-of-pocket costs are based on net pricing (that is, after rebates and discounts), their costs at the point of dispensing may decrease. This will not be the case for patients who are members of plans using fixed copayments for insulin and other products. But as Drug Channel Institute’s Adam Fein says, “The settlement helps shield patients from excesses of the gross-to-net bubble.”

“This settlement enables us to keep moving forward, and we appreciate the administration’s reinforcement of our commitment to pharmacy benefits that put Americans first,” Express Scripts said in the statement. “This is a meaningful step toward affordability for millions of families, and toward advancing the goal we share with the Administration of full transparency into prescription drug costs.”

Insulin is just the catalyst in this chain reaction. According to the latest Samsung Bioepis Biosimilar Market Report, the low WAC price of insulin glargine hovers around $18 for a single prefilled pen. On a per-patient basis, insulin is one of the least expensive biologics (at least facing biosimilar competition). Many more, higher-cost agents covered under the pharmacy benefit should follow suit.

The FTC has been called on for years to take a greater role in countering anticompetitive marketplace activities around biosimilars, including the use of patent thickets to block biosimilar competition and the use of misleading marketing information.

Significant PBM Reform Is Finally Achieved

The House of Representatives passed the long-awaited spending bill, and it was signed by President Trump on February 3rd. From the standpoint of health care, the bill failed to extend Affordable Care Act subsidies, but remarkably, major pharmacy benefit manager (PBM) reforms survived the final version.

Meaningful PBM Reforms, Including Rebate Pass Throughs

The Consolidated Appropriations Act of 2026 seeks to delink PBM compensation from Medicare part D list prices and subsequent rebates, opting instead for flat administrative fees. This action would reduce a PBM’s incentive to favor higher priced drugs over generics and biosimilars.

Second, the bill mandates that PBMs fully pass-through rebates they negotiate from manufacturers to plans and plan sponsors. Failure to comply with the provision may result in financial penalties imposed by the Centers for Medicare and Medicaid Services (CMS).

Third, PBMs will be required to report data to payers and plan sponsors at least every six months. The reporting must include data on rebates, formulary rationale, benefit design, spread pricing, and drug spending, all of which were infrequently shared in the past. This attempt at increasing PBM transparency should shine a significant light on the advantages of biosimilar products.

The Department of Health and Human Services will next have to specify the reporting requirements and timelines for implementation.

Rebates not Eliminated, but no Longer a Direct PBM Revenue Source

These reforms have long been sought by plan sponsors. The Act’s provisions go beyond public health plans, extending into the protected realm of ERISA and self-funded plans. In a press release, Shawn Gremminger, President and CEO of the National Alliance of Healthcare Purchaser Coalitions stated, “Today’s bipartisan passage is not only a policy win—it is a long overdue correction to a system that has lacked transparency for far too long. For years, employers have navigated a healthcare marketplace where critical information about pricing, rebates, and formulary decisions were kept out of view. These reforms finally level the playing field and put employers and working families first.”

Removing the ability of PBMs to retain rebate revenue is an important step to ensuring that the PBM acts in the best interests of their clients (i.e., as a fiduciary). However, this part of the equation is not yet been fully solved.

One interesting aspect of this foundational PBM reform is the extent it might stimulate the growth of PBM’s private-label brands. With the Big 3 PBMs already committing to various degrees the move to a pass-through rebate model, they will no doubt focus their efforts on replacing dwindling rebate revenue. Can anyone else imagine a new service fee charged by the PBMs, for simply negotiating the rebate?

The private-label biosimilar is one tool in their tool box, along with new and innovative service fees. It allows the PBM to use spread pricing, like a drug manufacturer, to pocket profits. The end result is that the PBM still has a conflict of interest, in trying to maximize its own profits by dispensing its private- label biosimilar, instead of another, perhaps less-expensive biosimilar agent.

Will These PBM Reforms Necessarily Increase Biosimilar Adoption?

Unfortunately, the rebate pass-through mandate by itself will not help biosimilar uptake: Payers will not be discouraged from preferring rebate-based pricing. Yes, rebates will still be a line item on a health plan’s or sponsor’s bottom line. Therefore, biosimilars with a low WAC price may still be disadvantaged compared with the originator when formulary decisions are made.

Rebates are not paid immediately to the plans, and I don’t believe that patients will benefit at the point of sale from the delayed savings with reduced co-insurance based on the lower net cost. That is yet to be seen. However, once larger employers see the more-transparent, mandated data reports from their PBM on rebates, lower net prices of biosimilars, and the low rate of biosimilar adoption (for biosimilars covered under the pharmacy benefit), the value biosimilars truly provide will also be transparent. This should be enough to demand formulary change—or a move to a PBM acting in the best interest of their clients and beneficiaries.

What TrumpRx Is, What It Is not, and Concerns for Biosimilars

TrumpRx is a hot topic today, especially in the context of its foundational concept: direct-to-consumer (DTC) or direct-to-patient (DTP) drug purchase and dispensing. Apparently set to launch, after the Department of Health and Human Services (HHS) issued a guidance that Secretary Robert F. Kennedy, Jr, said, “makes clear that manufacturers can offer lower-cost drugs directly to patients without kickbacks or taxpayer billing.” The site may be ready to launch as early as Friday, January 30.

There remains a good amount of confusion how, if at all, TrumpRx fits into this DTC scheme, and to what extent the very small DTC market may affect the far larger market of commercially covered pharmacy benefits. Organizations like Mark Cuban’s Cost Plus, GoodRx, Lilly Direct, and BlinkRx already exist as pharmacies where the available products, under low DTC pricing, can be purchased by patients and shipped directly to them.

TrumpRx: So What?

On its face, TrumpRx is simply a portal that would allow a search for specific drugs and then link to these DTC vendors. From the perspective of a patient, it is a gateway to vendors offering drugs that have been heavily discounted for direct purchase—no rebates, no deductibles, no counting towards deductibles, no copays. Just a straight monetary transaction at a discounted purchase price. TrumpRx does not facilitate the sale, it does not supply the discounted drugs, and it does not accept money for the purchase. It is supposed to be accessible to pretty much anyone—the uninsured, underinsured, Medicare eligibles, and Medicaid eligibles.

With any DTC purchase, none of the transactions are registered by pharmacy benefit managers or health plans: Other than the prescription made by a health care provider, no other information enters the electronic medical record or a payer’s administrative database/billing system. From the health plan, insurer, and PBM perspective, there’s not too much to love about DTC purchases.

TrumpRx makes deals with drug manufacturers to offer their products (not all, just specific ones) at a most favored nation (MFN) price to patients. If I understand the process correctly, the drugs will then be offered by the DTC pharmacies at the negotiated MFN discount. In the early infancy of the DTC movement, individual manufacturers negotiated directly with companies like Cost Plus, and the discounts could be far lower than the expected MFN price.

What Do TrumpRx Deals Actually Entail?

A completed negotiation with the White House would allow the manufacturer’s drugs to be listed on the TrumpRx site, and be exempt from tariffs. It is not clear whether we’re talking about tariff exemptions for only those specific drugs or for the entire manufacturer’s portfolio. Considering the inconsistency of pharmaceutical tariff threats by the administration, this could be a nightmare to track and administer (in either case).

It is also unclear whether a deal with TrumpRx will exempt a single drug or all the manufacturer’s drugs from participation in the Medicare GLOBE and GUARD models, which would apply to a much larger segment of the population.

According to a recent webinar by the Academy of Managed Care Pharmacy’s legislative and regulatory team of Adam Colburn and Tom Casey, the “new DTC prices may serve as benchmarks for negotiations between payers and manufacturers.” Read that quote again. They are saying that this could knock down drug pricing for the vast commercial market, not just for the market-share sliver of cash-paying customers.

Biosimilar Considerations in This Long View

I’m not ready to go that far, not yet, anyway. Think about the implications of this possibiliity though. It would be great news for payers and terrible news for the drug industry. Also, it would be a big fat negative for the biosimilar industry: This will lower potential revenue targets for biosimilar candidates (in the same way as the Inflation Reduction Act’s Medicare Maximum Fair Price initiative), making them less attractive for biosimilar development.

Remember that the sole reason for the existence of biosimilar competition (and the industry itself) is to lower pricing substantially for high-cost biologics at the end of their market exclusivity. If something like MFN pricing (based on today’s WAC prices) is used as a starting point for commercial, Medicare, and Medicaid drug pricing negotiation, it could immediately lop off half to two thirds of the price of a biologic drug. Suddenly, biosimilar competition becomes less urgent, doesn’t it?

In Other Biosimilar News

On January 27, The Centers for Medicare and Medicaid Services announced the list of the drugs subject to the third round of MFP negotiations (this year for implementation on January 1, 2028). The set of 15 drugs predicted by Cousin and co-workers, which we reported on earlier this month was nearly spot on. Several biologics that are potential biosimilar candidates were on the list, and only Simponi (golimumab) didn’t make the final cut. This leaves Cimzia, Orencia, Entyvio, Cosentyx, Xolair, and Botox as eligible biologics this year.

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.

An Injection of Support for the Biosimilar Red Tape Elimination Act

Thirty-seven organizations representing manufacturers, health plans and insurers, pharmacy benefit managers, corporate employers, consumers, and patients have banded together to support and hopefully reinvigorate action to pass the bicameral Biosimilar Red Tape Elimination Act.

The Biosimilar Red Tape Elimination Act has been long-awaited, but it is not making much progress through Congress. As of January 22, the House version (HR 5526) has four co-sponsors since its introduction in September 2025. The related legislation in the Senate (S 1954) was introduced in early June last year, sat in Committee since that time, and similarly has gained only four co-sponsors.

In October 2025, FDA Commissioner Marty Makary, MD, stated that a draft guidance was being written to address the same objective—redefine interchangeability for biosimilars so that any approved biosimilar is deemed interchangeable. As of January 22, the bills are stuck in committee, and the FDA has not issued the anticipated draft guidance.

No Clinically Meaningful Difference Between Biosimilar and Interchangeable Biosimilars

The Association for Accessible Medicines announced the joint letter, which was sent to the chairmen and ranking members of the House and Senate committees, where the bills currently reside, asking them to “advance this crucial legislation.”

“There is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” said John Murphy III, President and CEO of AAM. “Interchangeability is a designation created by legislative language instead of science, doesn’t exist in any other country. We are thankful to the bill sponsors in the House and the Senate as well as the many groups who have joined us.”

“Unfortunately, the statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines,” states the letter. “The [FDA] has consistently affirmed that there is no scientific difference between biosimilars and interchangeable biologics.”

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.

AbbVie, MFN, and a World of Ambiguity

On January 12, AbbVie announced that it had reached an agreement with the Trump administration on participation in its most favored nation (MFN) pricing initiative, and making certain medications available through its direct-to-consumer platform.

With the various agreements made with 15 other pharmaceutical companies, specific drugs were not disclosed. This is the first time in the short history of the MFN initiative that it involves a reference product with active biosimilar competition—that is, of publicly disclosed information.

However, the MFN (and Medicare maximum fair price for that matter) programs were explicit in their intent to avoid interfering with the biosimilar and generic marketplaces. For their part, AbbVie may simply be seeking another access channel to forestall fading Humira volume. It is not expected that the TrumpRx direct-to-consumer channel would be particularly strong.

What Is the MFN Price of Humira Likely to Be?

What would be the MFN price of Humira? Data on which the calculation derived from the administration’s international pricing index of countries with comparable economies are a bit dated, and the source has not been verified. Based on 2023 prices, Humira pricing ranges from $875 per 40 mg dose in Italy to $316 in France (of countries included in the MFN international index). Many of the adalimumab biosimilars are already providing deep discounts (some greater than 85%), to a price range of $450 to $693 for the same dose. At least one biosimilar is available through Mark Cuban’s Cost Plus at a 92% discount. What AbbVie offers under TrumpRx is unknown, but for cash paying buyers, Humira monthly cost will likely be hundreds of dollars, and largely unaffordable for most.

The point is that the biosimilar industry needs no additional impediment to its success, and most certainly, not in the adalimumab category. The reference product still retains the largest market share, and several adalimumab biosimilar makers are hanging on with miniscule volume.

In its rush to make TrumpRx MFN deals, the administration seems to have run roughshod over its own stated intention, to protect the biosimilar segment from harm. Simply, did AbbVie seek to include Humira in the arrangement, and the administration paid inadequate attention? Or did the administration seek to include Humira because of its boldface status, which would have been even stranger?

A Lack of Foresight or Lack of Principles?

Either way, this move sends a signal that the administration is conflicted about signing MFN deals for other reference drugs with active biosimilar competition. This isn’t an unintended consequence of the MFN policy; it’s a self-inflicted wound.

My original worry was that MFN, like Medicare’s maximum fair price negotiations, will discourage investment in biosimilar development. This was a problem for prospective biosimilar developers, I thought, not those with existing, approved biosimilars.

This seeming misstep is likely the result of the same “move fast and break things” mentality that has characterized this administration from the beginning of its second term. This was not a deeply considered move.

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.

Samsung Bioepis Reinforces Its Biosimilar Pipeline

For biosimilar industry watchers like BR&R, Samsung Bioepis has played a leading role in introducing biosimilars to the US market, first with its infliximab biosimilar Renflexis. Over the years, as their biosimilar candidates were approved by the FDA, the pipeline appeared to thin, with pembrolizumab (SB27) being the sole publicly disclosed biosimilar candidate, as of the beginning of this week.

That changed very suddenly on January 15, when Samsung Epis Holdings, the parent of Samsung Bioepis, announced a healthy new slate of biosimilar candidates in early-stage development. The six additions to the pipeline include:

Dupilumab (reference product, Dupixent) (earliest main patent expiration, 2031)
Guselkumab (Tremfya) (2031)
Ixekizumab (Taltz) (2030)
Vedolizumab (Entyvio) (2028)
Ocrelizumab (Ocrevus) (2029)
Fam-trastuzumab deruxtecan (Enhertu) (2033)

When queried by E-mail, Samsung Bioepis added that each of these biosimilar candidates were developed in-house and were not licensed from other biopharmaceutical companies.

In the announcement, Kyung-Ah Kim, President and CEO of Samsung Epis Holdings, stated, “We are making great progress to secure 20 biosimilars in our portfolio by 2030.”

In addition to the newly announced biosimilar pipeline, Samsung Bioepis also updated its efforts to produce novel therapeutics. These include an antibody conjugate (SBE303) for oncology indications, which is entering phase 1 trial. This investigational innovator agent was partly the result of a global partnership with Phrontline Biopharma. The company intends to introduce “one novel therapeutic candidate into clinical study every year.”

(Editor’s Note: The anticipated patent expiration dates are obtained through multiple sources, based on composition-of-matter patents. However, patent litigation that delays commercialization may extend beyond these principal patents.)

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.