The second quarter of 2025 has brought a steady flow of movement in the FDA pipeline, biosimilars gaining even more traction, and high-cost therapies making headlines. And with PBMs already adjusting formularies midyear, it’s clear that benefits teams need to be paying attention.
Here’s what’s new—and what it means to your strategy.
New Approvals to Watch
Romvimza (vimseltinib)
The second FDA-approved therapy for tenosynovial giant cell tumor (TGCT) is now available—and it’s already drawing comparisons to Turalio. While Romvimza’s wholesale cost is 16% higher, it lacks the black box liver warning and REMS restrictions that limit Turalio’s use.
Payer considerations: Romvimza should require prior authorization with a response-based renewal—its high cost of $339K/year makes tight utilization essential.
Blujepa (gepotidacin)
Blujepa is a novel oral antibiotic approved for uncomplicated UTIs in females ages 12 and up. With antibiotic resistance on the rise, this brings a promising new mechanism of action—but at an expected cost of up to $1,000 for a 5-day course, it will likely be reserved for patients who fail first-line generics.
Payer considerations: Step therapy through less expensive generic antibiotics should be required along with quantity limits.
Qfitlia (fitusiran)
Qfitlia offers a new treatment for routine prophylaxis in Hemophilia A and B, regardless of inhibitor status. Dosed subcutaneously every two months via a pre-filled pen, this new medication is positioned for convenience and broad indications.
Payer considerations: With an annual WAC of $928K (potentially double with monthly use), Qfitlia is now the highest-priced hemophilia maintenance therapy. Consider step edits through Hemlibra or coagulation factors.
Generics on the Rise
Q2 brought a wave of generic launches, including:
- Xarelto (2.5mg)
- Brilinta
- Aptiom
- Qsymia
- Jynarque
- Promacta
- Tasigna
While early competition is still limited for several drugs, additional manufacturers are slated to enter the market throughout the year—particularly for blockbuster therapies like Entresto, expected to face generics beginning as early as July 2025 (pending litigation outcomes).
Humira & Stelara Biosimilar Updates
The biosimilar market continues to gain momentum, with more organizations shifting away from originator products in favor of lower-cost alternatives. CVS Caremark led the charge in April 2024 by removing Humira from its commercial formularies. Navitus followed later that year. As of July 1, 2025, additional PBMs—including Express Scripts, OptumRx, and Livinity—will implement formularies that exclude Humira in favor of biosimilars.
The first quarter of 2025 also introduced biosimilar competition for Stelara. PBMs responded swiftly, adding these alternatives at parity with the originator. Navitus, OptumRx, and Livinity are once again leading the way—effective July 1, 2025, and will offer formularies that remove Stelara in favor of lower-cost biosimilar options.
| Originator | PBMs Removing Originator | Preferred Biosimilars | Effective Date |
| Humira | Express Scripts | adalimumab-adaz, adalimumab-adbm (Quallent), adalimumab-ryvk (Quallent), Cyltezo, Simlandi, | 7/1/25 for most formularies |
| OptumRx | Amjevita | ||
| Livinity | Adalimumab-aaty, adalimumab-adaz | ||
| Stelara | Navitus | Yesintek, Steqeyma, ustekinumab-aekn(Anda) | 7/1/25 for most formularies |
| OptumRx | Wezlana | ||
| Liviniti | Selarsdi, Steqeyma, Yesinteck |
Payer considerations: These changes open doors to cost savings but require close oversight to manage member transitions and ensure clinical alignment.
Additional Biosimilars Entering the Market
Denosumab (Prolia/Xgeva) biosimilars are launching with discounts ranging from 5% to 14.5%, offering new paths to savings in high-cost bone health and oncology-related therapies.
- Denosumab (Prolia) Biosimilars
- Jubbonti – (Sandoz)
- Stoboclo – (Celltrion)
- Ospomyv – (Samsung Bioepis)*
- Conexxence – (Fresenius Kabi)*
- Denosumab (Xgeva) Biosimilars
- Wyost – (Sandoz)
- Osenvelt – (Celltrion)
- Xbryk – (Samsung Bioepis)*
- Bomyntra – (Fresenius Kabi)*
*Have not launched yet
What This Means for Plan Sponsors
The second half of 2025 will demand thoughtful formulary management and proactive cost-containment strategies.
We recommend:
- Tight utilization management for high-cost new entrants
- Strategic review of biosimilar adoption opportunities
- Monitoring of generic pipeline pricing shifts
- Evaluation of new therapies’ cost-benefit relative to existing options
As best practices evolve, our team of clinical pharmacists and benefit strategists can help you navigate the impact on your plan. From formulary optimization to cost-containment strategies, we’re here to help you stay aligned with care quality and your bottom line.
