The third quarter brought new pharmacy developments for plan sponsors to watch, including approvals in COVID-19 prevention, cholesterol management, ADHD and pancreatic cancer. Some introduce new mechanisms or more convenient routes of administration, while others raise familiar benefit-management questions around appropriate use, formulary placement, cost and member access.
At the same time, generic launches and biosimilar activity continue to create opportunities for lower-cost alternatives. Together, these updates give employers, TPAs and advisors several areas to monitor as they evaluate pharmacy spend and strategy.
New FDA Approvals to Watch in Q3 2026
Xocova (ensitrelvir)
Xocova was approved on May 29, 2026, for post-exposure prophylaxis of COVID-19 in individuals age 12 and older following contact with someone who has COVID-19. As the first oral FDA-approved treatment to prevent symptomatic COVID-19 following confirmed exposure, Xocova represents a new addition to the U.S. COVID-19 landscape.
- Utilization Management: Because of the narrow treatment window following COVID-19 exposure, plans should balance utilization controls with timely access. If employed, prior authorization needs to be efficient and timely as slower PA processes could delay therapy initiation. Quantity limits can help support appropriate dosing and utilization. Edits to avoid use during pregnancy should also be considered.
- Cost Impact: WAC is $1,400 for the five-day treatment course.
- Clinical Considerations: Xocova is not FDA-approved for the treatment of active COVID-19 infection, creating the potential for off-label use beyond its approved indication. It may also cause fetal harm and should not be used during pregnancy.
Lipfendra (enlicitide)
Lipfendra was approved on July 15, 2026, as an adjunct to diet and exercise for reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
- Utilization Management: Prior authorization or step therapy, along with quantity limits, may help confirm diagnosis, disease severity, labeled use and appropriate patient selection.
- Cost Impact: Annual WAC is $3,833, approximately 45%–50% lower than the WAC of the injectable PCSK9 inhibitors Praluent ($6,984 annually) and Repatha ($7,594 annually).
- Clinical Considerations: As the first oral PCSK9 inhibitor approved for LDL-C lowering, Lipfendra enters a competitive market that already includes generic statins, ezetimibe and injectable PCSK9 therapies. Its LDL-C-lowering efficacy and oral formulation may make it an attractive option for patients who need additional lipid lowering or prefer to avoid injectable therapy.
Simtriyo (centanafadine)
Simtriyo was approved on July 24, 2026, for the treatment of ADHD in adults and pediatric patients age 6 and older. Simtriyo is the first ADHD treatment in a new class of norepinephrine, dopamine and serotonin reuptake inhibitors, offering a different mechanism from established stimulant therapies.
- Utilization Management: Prior authorization, step therapy and quantity limits may help confirm diagnosis, disease severity, labeled use and appropriate patient selection and dosing.
- Cost Impact: WAC remains pending, as Simtriyo has not yet launched in the U.S.
- Clinical Considerations: No head-to-head trials with established ADHD stimulants have been conducted, leaving its comparative efficacy and tolerability unclear. Commercial availability is expected later this year following completion of DEA scheduling.
Rasonque (daraxonrasib)
Rasonque was approved on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. It is considered a first-in-class therapy in pancreatic cancer, offering a new approach for a disease with historically limited treatment options.
- Utilization Management: Prior authorization and quantity limits may help confirm diagnosis, disease severity, labeled use and appropriate patient selection and dosing.
- Cost Impact: Monthly WAC is $39,800.
- Clinical Considerations: Clinical trial data demonstrated meaningful improvements in survival outcomes. With pancreatic cancer often diagnosed at an advanced stage when treatment options are limited, Rasonque represents an important new treatment option but also introduces substantial cost considerations for plans.
Select Generic Launches
Generic activity continues across several categories. The level of current and expected competition varies considerably by product, which may affect future pricing pressure and savings opportunities.
| Brand Name | Generic Name | Generic WAC | Discount to Brand WAC | Launch Date | Comments |
| Januvia | sitagliptin phosphate | $8.98/tab | 18% | 05/28/2026 | 3 generic competitors launched; 21 additional manufacturers expected |
| Janumet | sitagliptin phosphate/metformin | $4.36/tab | 21% | 05/28/2026 | 2 generic competitors launched; 18 additional manufacturers expected |
| Xeljanz tablet | tofacitinib citrate | $4.99/tab (5 mg*) | 93% | 06/03/2026 | 8 generic competitors launched; 10 additional manufacturers expected |
| Xeljanz XR (11 mg tablet) | tofacitinib citrate | $46.41/tab | 78% | 06/03/2026 | 10 generic competitors launched; 2 additional manufacturers expected |
| Xeljanz XR (22 mg tablet) | tofacitinib citrate | $184.53/tab | 14% | 06/03/2026 | 1 generic competitor launched; 10 additional manufacturers expected |
| Xeljanz oral solution | tofacitinib citrate | $9.29/ml | 57% | 06/03/2026 | 4 generic competitors launched; 2 additional manufacturers expected |
| Opsumit | macitentan | $38.83/tab | 91% | 06/08/2026 | 10 generic competitors launched; 3 additional manufacturers expected |
| Bosulif | bosutinib monohydrate | $593.30/tab (500 mg*) | 20% | 06/11/2026 | 1 generic competitor launched; 2 additional manufacturers expected |
| Injectafer | ferric carboxymaltose | $102.69/ml (750 mg/15 ml*) | 10% | 07/01/2026 | 2 generic competitors launched; 6 additional manufacturers expected |
| Rhofade | oxymetazoline HCl | $22.68/gm | 8% | 07/15/2026 | 2 generic competitors launched; 2 additional manufacturers expected |
| Janumet XR | sitagliptin phosphate/metformin | $4.95/tab (50-1000 mg*) | 10% | 07/24/2026 | 1 generic competitor launched; 15 additional manufacturers expected |
| Priftin | rifapentine | $5.00/tab | 1% | 07/27/2026 | 1 generic competitor launched; no additional manufacturers expected |
| Nuedexta | dextromethorphan hydrobromide/quinidine sulfate | $22.23/cap | 20% | 07/30/2026 | 2 generic competitors launched; 5 additional manufacturers expected |
*WAC price varies by strength
Biosimilar Approvals and Launches Continue in Q3 2026
Biosimilar activity also continued across oncology, ophthalmology, diabetes and other high-cost categories:
- Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta, was approved on May 7, 2026, for oncology and radiation-exposure indications.
- Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis, was approved on June 2, 2026, for retinal conditions including wet age-related macular degeneration and diabetic macular edema.
- Garzulys (insulin aspart-fsan), a biosimilar to Novolog, was approved in July, expanding competition in the rapid-acting insulin biosimilar market.
While Ennumo, Ranluspec and Garzulys have not yet entered the U.S. market, Omlyclo (omalizumab-igec), an interchangeable biosimilar to Xolair approved in March 2025, launched this quarter as the first Xolair biosimilar in the U.S. at a 15% discount to Xolair’s WAC.
What Q3 2026 FDA Drug Updates Mean for Plan Sponsors
This quarter’s developments show the competing forces shaping pharmacy benefits: new therapies are expanding treatment options and introducing new cost considerations at the same time that generic and biosimilar competition creates opportunities for greater affordability.
For employers, TPAs and plan sponsors, the practical question is how each new entrant fits into the broader benefit. Clinical value, expected utilization, available alternatives, formulary positioning and cost should all factor into coverage and management decisions. Generic and biosimilar competition also requires continued monitoring, since initial launch pricing and the number of competitors entering a category can influence how savings opportunities develop over time.
Staying close to these changes can help plans make more informed formulary and utilization decisions while identifying opportunities to manage pharmacy trend without compromising appropriate member access.
Need help evaluating how new therapies and market changes could affect your pharmacy benefit strategy? Navion helps plan sponsors and their partners make more informed formulary, utilization and cost-management decisions.
