National CooperativeRx Pipeline Report 2026

National CooperativeRx constantly monitors the pharmaceutical pipeline for new drugs that will be entering the market. As treatment options change, it’s important to know which medications bring the highest value, as well as which could disrupt current trends. Our Pipeline Report provides insight from our clinical team into what changes you can expect to see in the market and how they impact plan performance.

Awiqli (insulin icodec)¹: First once-weekly, ultra-long-acting basal insulin. After being rejected in 2024 for use in type 1 diabetes, Novo Nordisk resubmitted for use in type 2 diabetes, and the FDA is set to review in March 2026. This product serves to improve patient adherence and satisfaction. Awiqli is already approved in Canada, and the UK, as well as other countries around the world. Studies surrounding this product show it controls blood glucose at least as well, if not better, than treatment with insulins glargine U100, glargine U300, and degludec (other long-acting insulins). The safety profile for Awiqli was similar to other marketed insulins; however, it did have higher hypoglycemic event rates (low blood sugar), hence the FDA’s original denial.

• Patient impact: high; estimates state as many as 35 million Americans have type 2 diabetes, making it a common diagnosis for National CooperativeRx members.
• Plan impact: high; though cost is not available in the US, list prices in Canada are about $1,100 per month compared to a wholesale price of $425 per month for insulin glargine U100.

Lerochol (lerodalcibep)²: This is a new PCSK9 inhibitor, similar to Praluent and Repatha, recently FDA approved for the treatment of high cholesterol. Medication was approved based on studies that showed significant LDL (bad cholesterol) reductions (up to 60%) with tolerability comparable to other medications in the same class. Additional benefits of Lerochol include extended room temperature stability (other products must be refrigerated), as well as once-monthly vs. bi-weekly administration. Medication is FDA-approved and set to become market available in spring 2026.

• Patient impact: medium; while high cholesterol is a prominent condition, most patients do not progress to needing specialty treatment with PCSK9 inhibitors.
• Plan impact: medium; relatively low use compared to other classes of medications for cholesterol but high cost and moderate use could impact spend.

Orforglipron³: This product from Eli Lilly is an oral GLP-1 agonist indicated for the treatment of obesity in adults. Results from a phase III study showed superior weight maintenance over 52 weeks in comparison to placebo. Additionally, patients who were switched to orforglipron from another GLP-1 maintained weight loss. Safety and tolerability were shown to be similar to those of currently marketed GLP-1s. Estimates show this medication could hit the market sometime Q1 or Q2 2026.

• Patient impact: high, if a plan covers therapies for weight loss.
• Plan impact: high, GLP-1s are a driving factor in increased trend for a plan. Currently, National CooperativeRx has over 8,000 members on anti-obesity GLP-1s alone. While this product could represent replacement spend, it will be another option being marketed, and its oral formulation will make it more desirable than an injectable for some patients.

Anaphlym (epinephrine)⁴:  This product represents the first oral treatment for anaphylaxis (severe allergic reaction) for patients weighing 66lbs or more. The product is dosed as a sublingual film. Phase III studies determined that Anaphlym was absorbed faster and stayed in the body for a duration of time comparable to the currently available EpiPen and Avi-Q autoinjector products. The product was also well tolerated with similar adverse effect profiles. Anaphlym was pending FDA approval at the end of January 2026, however, the manufacturer was asked to update packaging for ease of use and labeling of product. An updated submission is expected Q3 2026. While classified as a replacement spend product, the appeal of an oral product over previously available injectables could make this product very popular immediately upon launch.  

• Patient impact: high; claims for injectable EpiPens are quite common for plans and this option could become very popular once launched.
• Plan impact: high; although costs for injectable epinephrine have been coming down over the past few years due to public scrutiny, this replacement spend could spike costs in the class if not properly controlled.

Camizestrant⁵: This product serves as the first targeted therapy for ESR1-mutated breast cancer in a first-line setting. The medication should be used in combination with another cancer medication once it is determined that a patient’s cancer has the ESR1 mutation. While not yet FDA approved, highly encouraging results were seen in in the SERENA-6 study that resulted in a 56% reduction in risk of progression or death and progression-free survival increased to 16.6 months from 9.2 months with standard therapy. Expected to launch Q1 2026, camizestrant could replace traditional treatment with endocrine therapy in patients with detection of an acquired ESR1 mutation.

• Patient impact: low; diagnosis of this type of cancer is rare.
• Plan impact: low; while costs are unknown at this point, plan trend should not be affected substantially.

Exdensur (depemokimab)⁶:  This product is an ultra-long-acting antibody that targets interleukin 5 (IL-5) and will be an additional treatment option for severe uncontrolled asthma in patients 12 years and older. This was recently FDA approved in December 2025. Exdensur will join other biologics for these conditions including Cinqair, Dupixent, Fasnera, Nucala, Tezpire, and Xolair. Medication will be administered every 6 months which will make it more advantageous than the other bi-weekly and monthly options. Phase III studies showed significant reduction in asthma exacerbations when compared with placebo. This product was not compared to another biologic for these indications, so it is not known how it would compare across the various biologics. Use of this product for treatment of chronic rhinosinusitis with nasal polyps is also under review by the FDA and a decision is expected early 2026.

• Patient impact: medium; while trend in this area is increasing, only a small percentage of members currently qualify for treatment with one of the products in these classes.
• Plan impact: low; this product represents mostly replacement spend. With the other agents also being brand only at this point, formulary placement and utilization management should hold spend on this product steady.

Icotrokinra⁷: This product is an IL-23 antagonist that would represent the first oral targeted therapy for plaque psoriasis. Phase III studies showed significant skin clearance when compared to placebo and even showed superiority to deucravacitinib/Sotyktu, which does have a different mechanism of action. Pending FDA approval, this product should be market available late 2026.  

• Patient impact: medium; while trend in this area is increasing, only a small percentage of patients currently qualify for treatment with one of the products in these classes.
• Plan impact: medium; this product represents mostly replacement spend. With the other agents also being brand only at this point, formulary placement and utilization management should hold spend on this product; however, with this product being an oral therapy, there could be more marketing/interest to make requests increase.

Civica Branded Insulin Glargine⁸: Not-for-profit drug manufacturer Civica is launching its low-priced insulin glargine as of January 1, 2026. Pricing for pharmacies will be $45 for 5 pens compared to over $400 wholesale for insulin Glargine. While formulary status is unknown, this is likely going to drive down costs of other glargine products, which will lower trend in the insulin space across the board.

Generic Launches: The following products have lost market exclusivity and will be launching generics in the first half of 2026.

• Neudexta (dextromethorphan/quinidine)⁹ is losing patent exclusivity in August 2026. There is a generic that has been FDA approved and should launch quickly after the patent expires. This is a treatment for the rare disease pseudobulbar affect (PBA), however, with 2024 annual sales of over $248M, any cost avoidance due to generic availability will be beneficial to payers.
• Januvia (sitagliptin)/Janumet (sitagliptin/metformin)⁹ is a medication used to treat type 2 diabetes. 2024 annual sales were over $6B. The generic should be available mid-2026.

Biosimilar Launches¹⁰: The growing number of biosimilars coming onto the market will continue to drive lower costs for payers. Below is a summary of some that may come to market in 2026.

• Simponi/Simponi Aria (Golimumab)¹¹, a TNF-a inhibitor made by Johnson & Johnson, is expected to lose exclusivity sometime in 2026. The medication is approved to treat ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis as well as ulcerative colitis. There are two biosimilar products in the works, one of which (BAT25006) could be approved as early as May 2026.
• Tocilizumab (brand Actemra)¹², while already having a pair of biosimilars on the market (Tyenne and Tofidence), another that could be available sometime in the first half of 2026. Avtozma, by Celltrion, has been approved by the FDA and is set to add competition to the market and lower costs of IL-6 antagonists.
• Xolair (Omalizumab)¹³ is expected to lose exclusivity mid-2026. There is one approved biosimilar (Celltrion) and three others either pending approval or in phase III trials. Celltrion should be available once loss of exclusivity occurs in the 2^nd half of 2026.