By Beckie Fenrick, PharmD, MBA and Jason Peterson, RPh
The first quarter of 2026 brought a steady flow of drug approvals and market developments that could affect pharmacy benefit strategy in the months ahead. Key updates include the first oral GLP-1 approved for chronic weight management, new specialty therapies for rare and high-cost conditions, the return of ranitidine to the U.S. market, and continued biosimilar and generic activity across several categories.
For plan sponsors, brokers, and TPAs, these developments are worth watching not only for their clinical significance, but for how they could shape utilization management, formulary decisions, and overall pharmacy spend.
Oral Wegovy (semaglutide) – New Approval
Oral Wegovy was approved in late Q4 2025 as the first oral GLP-1 receptor agonist indicated for chronic weight management in adults with obesity or those who are overweight with at least one weight-related comorbidity, used alongside diet and exercise.
Plan Sponsor Considerations
- Utilization Management: Prior authorization and quantity limits may be useful in supporting labeled use and appropriate patient selection.
- Cost Impact: WAC is $1,349 for 30 tablets, comparable to injectable Wegovy.
- Clinical Notes: As the first oral option in this category, this may appeal to members who prefer not to use injections. Significant demand is anticipated.
Redemplo (plozasiran) – New Approval
Redemplo is a small interfering RNA (siRNA) therapy approved in November 2025 for adults with familial chylomicronemia syndrome (FCS). It is intended to be used with a very low-fat diet to reduce severely elevated triglyceride levels and lower the risk of acute pancreatitis.
Plan Sponsor Considerations
- Utilization Management: Prior authorization should be tied to confirmed FCS diagnosis. Renewal criteria based on triglyceride response and dietary adherence may also be appropriate.
- Cost Impact: WAC is $15,000 per prefilled syringe for a three-month supply.
- Clinical Notes: Because FCS is rare and clinically distinct from broader triglyceride disorders, coverage criteria should be designed carefully to prevent inappropriate use in broader triglyceride management.
Exdensur (depemokimab-ulaa) – New Approval
Exdensur was approved in January 2026 as an ultra-long-acting injectable biologic and interleukin-5 (IL-5) antagonist for add-on maintenance treatment of severe asthma with an eosinophilic phenotype in patients 12 and older.
Plan Sponsor Considerations
- Utilization Management: Prior authorization and quantity limits are appropriate.
- Cost Impact: WAC is $26,000 per prefilled syringe for a six-month supply.
- Clinical Notes: Its twice-yearly dosing schedule may offer an advantage over more frequently administered biologics. Because it must be administered by a provider, it will likely fall under the medical benefit, making site-of-care and medical-pharmacy coordination important.
Lerochol (lerodalcibep-liga) – New Approval
Lerochol was approved in December 2025 as a PCSK9-targeting therapy for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and other lipid-lowering therapies.
Plan Sponsor Considerations
- Utilization Management: Prior authorization is appropriate and should require documented ASCVD and/or familial hypercholesterolemia, along with inadequate response or intolerance to maximally tolerated statin therapy. Step therapy aligned with existing PCSK9 policies may also be warranted.
- Cost Impact: WAC has not yet been announced.
- Clinical Notes: Lerochol enters a competitive LDL-lowering market that includes Repatha and Praluent, both monoclonal antibody PCSK9 inhibitors, as well as Leqvio, an siRNA therapy administered twice yearly under the medical benefit. Its monthly subcutaneous administration may position it between self-administered biologics and office-administered options.
Aqvesme (mitapivat) – New Approval
Aqvesme was approved in December 2025 for the oral treatment of anemia in adults with alpha- or beta-thalassemia, including both transfusion-dependent and non-transfusion-dependent disease. It is the first FDA-approved oral therapy for anemia across these forms of thalassemia and represents a significant advance in disease-modifying options for this rare inherited blood disorder. The approval also includes a Risk Evaluation and Mitigation Strategy (REMS) due to observed rare cases of hepatocellular injury requiring liver monitoring.
Plan Sponsor Considerations
- Utilization Management: Prior authorization should require documentation of diagnosis, anemia parameters, and specialist involvement such as hematology.
- Cost Impact: WAC is $32,610 for 56 tablets, or a 28-day supply.
- Clinical Notes: Unlike RBC transfusions, which are typically covered under the medical benefit, Aqvesme is likely to be covered under the pharmacy benefit, which may shift more cost into pharmacy spend. For patients who experience a meaningful reduction in transfusion burden, that impact may be partially offset by reduced need for high-cost iron chelation therapy.
Nereus (tradipitant) – New Approval
Nereus was approved in December 2025 as an oral neurokinin-1 receptor antagonist for the prevention of motion-induced vomiting in adults. It is the first newly approved treatment in this category in more than 40 years.
Plan Sponsor Considerations
- Utilization Management: Quantity limits are appropriate for episodic use. Step therapy beginning with lower-cost options may also make sense.
- Cost Impact: WAC has not yet been announced.
- Clinical Notes: Quantity limits are appropriate for episodic use. Step therapy beginning with lower-cost alternatives may also be appropriate, and prior authorization may be considered to help limit coverage to the labeled indication and reduce off-label use in other nausea and vomiting settings.
Ranitidine Returns to the U.S. Market
In November 2025, the FDA approved a reformulated version of ranitidine tablets for re-entry into the U.S. market at prescription strengths of 150 mg and 300 mg. The new formulation is designed to prevent the NDMA impurity issues that led to prior market withdrawal.
Whether OTC versions will return remains unclear, but the prescription re-entry is worth monitoring for future formulary and step-therapy implications in GI management.
Select Generic Launches
| Brand Name | Generic Name | Generic WAC | Discount to Brand WAC | Launch Date | Comments |
| Emflaza | deflazacort (branded as Kymbee) | $409.31 (30mg)* | 20% | 11/10/2025 | 5 generic competitors launched with no additional manufacturers expected to enter the market. |
| Cipro HC otic suspension | ciprofloxacin/ hydrocortisone | $32.80/ml | 10% | 11/24/2025 | Only 1 generic competitor launched with no additional manufacturers expected to enter the market. |
| Fycompa oral suspension | perampanel | $4.41/ml | 5% | 12/15/2025 | Only 1 generic competitor launched with no additional manufacturers expected to enter the market. |
| Rayos | prednisone | $ 78.23/tab | 15% | 12/17/2025 | Only 2 generic competitors launched with 1 additional manufacturer expected to enter the market. |
| Zylet | loteprednol etabonate/ tobramycin | $53.77/ml | 20% | 12/18/2025 | Only 2 generics launched with no additional manufacturers expected to enter the market. One of these is an authorized generic. |
| Besivance | besifloxacin | $ 41.36/ml | 10% | 01/06/2026 | Only 1 generic launched with no additional manufacturers expected to enter the market. This is an authorized generic launch. |
| Briviact oral solution | brivaracetam | $0.34/ml | 93% | 2/24/2026 | 5 generic competitors launched with 1 additional manufacturer expected to enter the market. |
| Briviact oral tablet | brivaracetam | $ 0.17/tab | 99% | 2/23/2026 | Only 2 generic competitors launched with 7 additional manufacturers expected to enter the market. |
* WAC price for Kymbee varies by strength
Biosimilar Approvals Continue
Biosimilar activity also remained strong this quarter. Boncresa and Oziltus, denosumab biosimilars referencing Prolia and Xgeva, were approved in December 2025. Nufymco, a ranibizumab biosimilar referencing Lucentis, was approved on December 18, 2025, further expanding competition across both bone health and ophthalmology categories.
Because denosumab and ranibizumab products are typically managed under the medical benefit, these approvals also reinforce the importance of evaluating biosimilar strategy beyond the pharmacy benefit alone.
Filkri (filgrastim-ayow)
Filkri, a filgrastim biosimilar referencing Neupogen, was approved on January 15, 2026 and is expected to launch later in 2026. The filgrastim market is already highly competitive, with seven FDA-approved products including the originator. Because filgrastim products may fall under either the pharmacy or medical benefit depending on site of care, Filkri is another reminder to evaluate biosimilar strategy across both sides of the benefit.
Final Thoughts on the Q1 2026 Drug Landscape
Q1 2026 reflects continued momentum across several high-impact areas, including weight management, rare disease, asthma, and biosimilars. For plan sponsors and their partners, the biggest takeaway is not just which products were approved, but how those products may influence utilization, benefit design, and pharmacy trend over time. The organizations that stay ahead of these developments will be better positioned to make informed formulary and coverage decisions as the year unfolds.
If you’re evaluating how these developments may shape your pharmacy benefit strategy, reach out to Navion to continue the conversation.
