Is There a Place for Private-Label Biosimilars Covered Under the Medical Benefit ?

Here’s a question that has been asked repeatedly over the last year or so: Does it make sense to have private label medical benefit-covered biosimilars?

We’ve seen the spread of private-label or “white-label” biosimilars, by the big 3 pharmacy benefit managers (PBMs) specifically, for adalimumab and ustekinumab. Although we’re not sure of current market utilization of the private-label versus non–private label products, we do know that the availability of the private-label products helped biosimilars on the road to uptake if not financial success.

We have in our sights some major medical benefit–covered reference products losing patent protection and marketing exclusivity over the next few years. These include Keytruda, Opdivo, Yervoy, Perjeta, and Ocrevus to name a few. All are high-cost agents that are important (if not critical) to patient care.

The discussion of a medical benefit private-label biosimilar must tease out the potential advantages/disadvantages for both the manufacturer and the provider (who in a buy-and-bill situation makes the initial prescribing decision) or payer (who decides on coverage/reimbursement). The first assumption is that PBMs generally deal far less with specialty drugs under the medical benefit (and especially oncology drugs). By their very name PBMs manage the pharmacy, not the medical, benefit. However, their affiliated specialty pharmacies are in a viable position to play an influential role, via white bagging. If that is the case, the provider’s buy-and-bill initiative would be lost, and they would be reimbursed solely for administration services. For PBMs, earning additional dollars through their specialty pharmacy, such white-labeled products seems highly promising.

The second assumption is that heavy competition at launch for medical benefit–covered biosimilars like Keytruda will result in huge, immediate net price discounts, as seen with the highly contested adalimumab and ustekinumab biosimilar launches. Competition is competition, regardless of how a drug is covered, so this is reasonable. The bigger question is whether Medicare price negotiation or most favored nations pricing hits before biosimilars launch (they shouldn’t, according to official and draft policy, but we should account for this anyway). A lower list price will mean lower cost savings for biosimilars.

A payer might be more neutral on the private-label issue. In general, private labels have not spelled greater net savings over low-WAC biosimilar versions of adalimumab or ustekinumab. They don’t seem to be extremely motivated to insist on non-private-label versus private-label biosimilar coverage. On the other hand, plan sponsors may think otherwise, based on the call for more PBM transparency. If the PD-1 inhibitor biosimilars, for instance, were available by private label through the specialty pharmacy, it would probably have little effect on payers except reducing buy-and-bill transactions for those specific products.

With the introduction of eight new Keytruda biosimilars competing for a $30 billion US market, discounts will quickly increase—regardless of MFP or MFN pricing. It should mean a virtual (delayed) free fall in average sales pricing (ASP), which will further dissuade providers from wanting to purchase these products and take on the risk of being caught underwater. If this follows, it drives purchases and distribution through the specialty pharmacy. Will the PBMs jump at the opportunity? Are there wholesaler or other relationships that they do not currently have to be in established first?

I don’t know the answers. I hope these thoughts spur a considered discussion of the advantages and disadvantages, and where this concept leads. Please lend your voice and comment on this topic.

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.

GLOBE, GUARD, and More MFN

Do you get the feeling we’re being deluged with news from the federal government on health regulation? That’s because we are. On December 23, the Centers for Medicare and Medicaid Services (CMS) got into the act again, announcing two new major demonstration projects that seek to cut pharmaceutical costs.

The Medicare Guarding US Medicare Against Rising Drug Costs (GUARD) and the Global Benchmark for Efficient Drug Pricing (GLOBE) models are further expansions of the Trump administration’s obsession with a Most Favored Nation (MFN) pricing approach. It has been openly discussed by the Trump administration since the President’s first term.

Whereas GUARD addresses Medicare part D covered products, GLOBE is focused on lowering the price of part B products. Biologic products are involved in both the GUARD and GLOBE models; the former includes small molecules as well. The notification language for both are identical in that they seek to avoid entangling biologics with existing biosimilar competition. Instead, eligible products are “single-source” agents only. However, like the Medicare Fair Price (MFP) provisions of the Inflation Reduction Act, this approach does not eliminate the likelihood that significant reductions in revenues of today’s single-source biologics will likely deter biosimilar development for these biologic targets tomorrow. Importantly, drugs already subject to MFP negotiations are exempted from eligibility in GLOBE and GUARD.

According to CMS, the GLOBE demonstration program will begin in October 2026 and continue for 5 years. It will be a mandatory project covering randomly selected geographic regions that will represent one-quarter of the total Medicare fee-for-service population. The GUARD demonstration program, also with mandatory participation, will begin in January 2027 and also continue for 5 years. It will cover geographic regions that represent 25% of Medicare part D plan membership.

More on the International Drug Pricing Benchmark

In terms of the MFN approach, the GUARD and GLOBE demonstration projects are consistent: They leverage an international drug pricing benchmark as a reference for drug reimbursement. It is based on drug payments in countries with a per capita gross domestic product that is within 60% of the US, and with an economy at least $400 billion in size. That includes countries like Australia, the United Kingdom, Israel, Denmark, among several others.

Another question regarding the international drug pricing benchmark is how often it might be recalculated. One of the most obvious responses by pharmaceutical manufacturers is to raise their prices in other countries, thus raising the indexed price of a drug. Also, if the pharmaceutical industry is successful in delaying the launch of these MFN-based demonstration projects, it may have ample time to boost global prices a bit. I would imagine that a 5-year demonstration period will capture this trend. One thing can be sure—prices in other countries will not be going down, unless new biosimilars are introduced!

Biosimilar Price Competition and MFN Pricing

Will the MFN approach result in lower prices than simply facilitating existing biosimilar competition and speeding its arrival? Whereas a drug like adalimumab is primarily covered under part D and would fall under the GUARD model, provider-administered agents like natalizumab would be administered by a provider and fall under part B.

The two cases can be very different in terms of pricing competitiveness. In the adalimumab case, intense competition has led to prices that are a small fraction of the original WAC price. For natalizumab, only Tyruko competes with the reference product Tysabri, and thus the wholesale average cost (WAC) difference between the biosimilar and the reference product is only 20% (based on a Drugs.com comparison). If Medicare MFP is any reference, we may be seeing one-third lower prices under GLOBE and GUARD compared with current WAC prices.

Average Sales Price Considerations in GLOBE

Under the GLOBE part B model, an important question arises as to whether it might affect or even replace average sales price (ASP)–based reimbursement for buy-and-bill products. Upon further reading, the notification specified that would not be the case. It would work as follows: The drug manufacturer would pay a rebate to the government to account for any differences between the international index price and CMS’s purchase price. This reconciliation would be made after the provider’s buy-and-bill (and reimbursement) transaction is completed. Simply put, the provider’s payment is unaffected by the later rebate. It may not be so simple, however. The ASP is supposed to incorporate all discounts and rebates. There seems to be no provision in GLOBE that the new potentially large rebates associated with eligible biologics will not be incorporated into the ASP price (thus driving it, and provider reimbursements, down).

In Other Biosimilar News

Amneal Biosciences announced on December 22 that it received FDA approval for its denosumab biosimilar denosumab-mobz to be sold under the names Boncresa and Oziltus (referencing Prolia and Xgeva, respectively). Amneal is partnered with mAbxience (which is majority owned by Fresenius Kabi) on this biosimilar; Amneal is responsible for commercialization rights in the US. This is the eighth denosumab approval in the US.

The Next Set of Biologics for Medicare Price Negotiations Predicted (and Eliminated?)

With this first post since the holidays, there is so much to discuss, yet so little firm ground on which to anchor the discussion. Since December 23, the Trump administration has added two more drug pricing reform models to the gordian knot of US pharmaceutical reimbursement, and authors from the University of Washington School of Pharmacy have published their list of drugs anticipated to be subject to Medicare price negotiation for year 3.

In this article, we’ll unpack the latter first, because it is straightforward (sort of). Based solely on Medicare expenditures and market exclusivity expiration, the researchers published in the Journal of Managed Care and Specialty Pharmacy what they believe will be the next round of drugs to be subject to Medicare price negotiation this year, for implementation January 1, 2028. The Table below lists the following biologics (of 15 identified drugs in total).

TABLE: POTENTIAL BIOLOGICS FOR MEDICARE PRICE NEGOTIATION IN 2026 FOR 2028 IMPLEMENTATION

Reference Product Brand Name	Nonproprietary Name	US Biosimilar Candidates Publicly Disclosed?*	Potential Launch of Biosimilars
Trulicity	Dulaglutide	Possible†	≥ 2030
Orencia	Abatacept	Yes (≥ 2)	≥ 2028
Entyvio	Vedolizumab	Yes (≥3)	≥ 2028
Cosentyx	Secukinumab	Yes (2)	2027
Xolair	Omalizumab	Yes (≥5)	2026
Cimzia	Certolizumab	Yes (≥1)	2027
Botox	Onabotulinumtoxin A	Possible†	N/A
Simponi	Goliumumab	Yes (2)	2026/2027

Number of existing candidates indicated in parentheses. Some manufacturers have indicated work on several upcoming biosimilars, without specifying individual molecules. Therefore, the existence of undisclosed candidates must be considered. †One Chinese dulaglutide candidate identified, but may not be intended for US market. Previous Botox candidate was announced pre-2020, but no updated information exists. Sources: Cousin EM, Martin K, Hansen RN, et al. J Manag Care Spec Pharm*. 2026;32(1):3-13; BR&R research.

This sunset of drugs represents the first time several biosimilar targets are included (as it is the first inclusion of part B drugs). Almost all drugs in the Table are covered to an extent under both part B and D. Indeed, the vast majority are currently the subject of biosimilar development. Some of these biosimilars will likely launch prior to 2028, before the negotiated Medicare price takes effect. Of course, predicted launch dates are dependent on patent settlements. The authors point out that other drugs are left off the list because their biosimilars are already marketed (e.g, aflibercept and denosumab) or eligibility is delayed by orphan drug rules (e.g., pembrolizumab and nivolumab, which will be eligible for selection in 2027).

If the Centers for Medicare and Medicaid Services (CMS) determine that a biosimilar launch is imminent, a request for delay in eligibility will be considered. However, CMS may seek negotiated prices if a request is not submitted, as occurred with ustekinumab. This will likely shrink the potential biosimilar revenues for these individual products. The reason CMS targets these products is that they are blockbusters. That is also the reason biosimilar manufacturers are interested in these biologics. With Medicare paying about one-third less for these agents in 2028 before biosimilar approval is obtained, they will be less interested in commercializing those agents. Consider the potential for limited market share (e.g., adalimumab), expensive patent litigation battles (e.g., nearly all products), and opportunity costs (i.e., against developing their own proprietary branded products).

Furthermore, if the ustekinumab experience is any reference, the negotiated Medicare Fair Price (MFP) will be well above the price that results from competition with several agents. The FDA is actively seeking to remove late-phase comparative trial requirements in an effort to lower development costs and reduce time to commercialization.

Today, it may make sense to modify CMS’s criteria for determining whether biosimilar launch is imminent. If a biosimilar product is already approved by FDA, this should take the reference product off the table for MFP eligibility. If three or more biosimilar products are actively in development (i.e., with FDA consultations or early-stage trials in progress) that should also eliminate the reference product from eligibility. I define three drugs as the threshold, because it should encourage significant price competition.

Drug payment and approval policies in this administration are moving all at once. We’ll review the latest salvo from CMS in the next post. However, with several biologics on the MFP list, the administration should review exactly what the value of biosimilar competition really is and how then to preserve it.

Avoiding Patient Disruption in Frequent Biosimilar Switching: A Focus on the Specialty Pharmacy

A long-time member of a national health plan, Ms. Jones had been utilizing adalimumab biosimilar A for the past 18 months. It had been the preferred adalimumab product and thus is associated with the least out-of-pocket cost. On January 15, she opens her newly delivered medication, and finds a different biosimilar medication, with a different autoinjector, in the package. She wonders (1) why, (2) whether this will affect her autoimmune disease, and (3) how it may affect the administration of her medicine.

Well, readers of these posts all know the “why.” They also know that a change in biosimilar therapy shouldn’t affect her clinical status, based on millions of patient-days of experiential data.

To delve into the third question, we asked Kam Ghazvini, RPh, Chief Executive Officer of CarePartners Pharmacy, a specialty pharmacy based in Libertyville, Illinois. “The autoinjector device can be different,” based on each manufacturer’s own proprietary design, he said. “The actual appearance, shape, feel, button placement, click feedback, needle gauge or buffer formulation, and instructions for use might vary between devices.”

This may be the underlying patient disruption that providers often express as a significant barrier to self-administered biosimilar adoption. Despite a great deal of evidence that changing formulary coverage does not affect disease control or safety, this is a stubborn challenge. Doctors don’t want to field calls asking why they changed their patients’ prescription, when they really didn’t. Health plans want the change to go as smoothly as possible, but they know that some (if not a majority) of patients do not read (or perhaps understand) advance notifications of a formulary change.

In fact, the specialty pharmacy can be a powerful tool to minimize patient disruption in cases like Ms. Jones. Mr. Ghazvini explained, “We are seeing formulary-driven biosimilar transitions occurring in 2025 and anticipate a meaningful increase in 2026. At CarePartners, these transitions are managed proactively and clinically, with a strong emphasis on patient education, safety, and continuity of care. Once a formulary change is identified, our team contacts the member in advance of the transition to explain the change and provide education on biosimilars in general, as well as on the specific biosimilar brand that will be dispensed.”

He added that in the case of a reference product to biosimilar transition, “every effort is made to maintain consistency in the delivery device. For example, if a patient has been using a Humira autoinjector, we typically dispense a biosimilar autoinjector rather than a prefilled syringe, whenever clinically appropriate and available.”

If a change in injection device is required, his organization’s clinicians proactively discuss this with the patient before dispensing. “Education includes clear instructions on device use, storage, and administration technique.” Mr. Ghazvini explained that at CarePartners, “our education and support approach varies slightly based on the patient access model, but clinical rigor remains consistent across all scenarios:

“(1) Direct from the patient: When CarePartners receives prescriptions directly from providers, our clinicians contact patients prior to dispensing to educate them on the transition from reference product to biosimilar; review safety, side effects, storage, and injection technique; and explain available patient-support and financial assistance resources.

“(2) PBM and Plan Sponsor Partnerships: Many of our PBM and plan sponsor partners have member-support teams that notify patients of formulary changes and provide high-level biosimilar education before transitioning members to our specialty pharmacy. CarePartners clinicians then reinforce this education and provide detailed clinical and device-specific training.

“(3) Wholesale and Distribution Model: Through our wholesale and distribution platform, we supply low-net-cost biosimilars to partners who operate their own pharmacies. In these cases, our clinical team provides comprehensive patient and provider educational materials for use at the point of dispensing.”

Mr. Ghazvini concluded, “CarePartners has dispensed and supported thousands of patients on biosimilar therapies over the past several years, with less than 1% of patients reverting back to reference products. We believe biosimilars demand a true specialty pharmacy model—one that prioritizes clinical oversight, patient education, and high-touch support to ensure optimal outcomes.”

In Other Biosimilar News

Alvotech and its marketing partner Teva Pharmaceuticals have reached a licensing agreement with Regeneron, which will enable it to launch its aflibercept biosimilar candidate AVT06, no later than during the fourth quarter of 2026 in the US. The drug’s 351(k) application is expected to receive an FDA decision early in 2026.