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.
