US Pharmaceutical Pipeline Expands With Innovation and Competition

2025 is expected to bring a number of new traditional and specialty pharmaceuticals, including the first generic and biosimilar competitors for blockbuster brands and innovative therapies for cancer and neurological disorders, according to 2 presentations at the annual meeting of the Academy of Managed Care Pharmacy.1,2

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Before getting into the generics and 505(b)(2) products coming down the pipeline, Leslie Fish, PharmD, RPh, senior vice president of pharmacy at IPD Analytics, provided a basic understanding of what’s preventing certain products from coming to market, particularly legal issues.1 These issues include companies choosing to launch products at risk, delayed launches as part of settlement agreements, skinny labels preventing generics from having access to the originator’s full market, and patent thickets. Patent thickets occur when originator manufacturers obtain subsequent patents on a product after it’s been on the market, often considering manufacturing processes.3 These patents allow originator companies to extend their market exclusivity far past their original patent’s expiration date.4

“It's like baking a cake. You want to put a patent on your cake, but you not only have a patent on the cake. You have a patent on that particular wooden spoon that you stir it with. You have a patent on the oven that you used it with. The patents end up working [to extend exclusivity] together and that's how these patent thickets occur,” she explained.1

Fish provided an overview of the 20 small molecule drugs expected to face generic competition at some point in 2025, including those for blockbuster agents rivaroxaban (2.5 mg only; Xarelto; direct-acting oral anticoagulant), sacubitril/valsartan (Entresto; cardiovascular), eltrombopag (Promacta; thrombocytopenia), tolvaptan (Jynarque; renal disease), linagliptin (Trajenta; diabetes), and macitentan (Opsumit; pulmonary), all of which have annual sales of $1.5 billion or more.

Additionally, 9 new drug applications (NDA) are awaiting FDA approval under the 505(b)(2) pathway. This includes 3 therapies for migraine—including 1 injectable, 1 nasal therapy, and 1 oral agent—as well as 2 drugs for hypertension, 1 for chronic kidney disease (CKD), 1 for fibromyalgia, 1 nasal agent for anaphylactic reactions, and 1 for deep vein thrombosis or acute pulmonary embolism.

Other branded medicines with new indications pending include brexpiprazole (Rexulti) for posttraumatic stress disorder, roflumilast (Zoryve) for scalp psoriasis, ruxolitinib (Opzelura) for atopic dermatitis and prurigo dermatitis, tirzepatide (Zepbound) for heart failure in patients with obesity, lumateperone tosylate (Caplyta) for major depressive disorder and schizophrenia, and finerenone (Kerendia) for heart failure and CKD. Some notable approved products awaiting launch in 2025 are apomorphine for Parkinson disease, etripamil (Cardamyst) for supraventribular tachycardia, acoltremon for dry eye disease, and suzetrigine (Journavx), a nonopioid pain medication.

She and her colleague, Jeffrey Casberg, RPh, MS, also senior vice president of pharmacy at IPD Analytics, chronicled the list of vaccines in the pipeline, which involved a new meningococcal vaccine to compete against Pfizer’s 5-valent vaccine. A combination vaccine for COVID-19 and influenza is also in the works.

Casberg also went into detail about the approved biosimilar products waiting to launch, noting the early movement in the ustekinumab space, in which biosimilars have been slowly launching since mid-January 2025.1,5 Interestingly, he shared that only 1 biosimilar company has chosen to adopt a dual-pricing strategy similar to those seen in the adalimumab space.1,6

“For those who are putting out drugs or managing costs with biosimilars, we're going to be talking about biosimilars for years to come. There's a lot to do here,” he proclaimed.

Maria M. Lowe, PharmD, BCPS, associate vice president of pharmaceutical intelligence at the Institute for Clinical and Economic Review, began her presentation on specialty agents with an overview on how approvals in 2024 fared compared with previous years, showing that the total number of FDA approvals have returned to prepandemic levels.2

She went on to spotlight some of the major specialty drugs approved last year, including approvals in cardiology (n = 1), dermatology (n = 3), gastroenterology (n = 2), endocrinology and metabolism (n = 8), hematology (n = 6), immunology (n = 3), and neurology (n = 2).

Lowe went on to highlight some of the anticipated agents in development, such as gene therapies for epidermolysis bullosa (n =3), a glycogen-like peptide-2 agonist for short bowel syndrome, 2 therapies for Fabry disease, 9 regimens for hypercholesterolemia, a gene therapy for Fanconi anemia, and 7 therapies for Duchenne muscular dystrophy, among others.

References

1. Fish L, Casberg J. Drug pipeline: traditional pharmaceuticals (brands and generics). Presented at: AMCP 2025; March 31-April 3, 2025; Houston, TX. Accessed April 7, 2025.

2. Lowe MM. Specialty pharmaceuticals in development. Presented at: AMCP 2025; March 31-April 3, 2025; Houston, TX. Accessed April 7, 2025.

3. Santoro C. Patent dance insights: a Q&A on reducing legal battles in the biosimilar landscape. The Center for Biosimilars®. August 18, 2024. Accessed April 7, 2025. https://www.centerforbiosimilars.com/view/patent-dance-insights-a-q-a-on-reducing-legal-battles-in-the-biosimilar-landscape

4. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars. November 11, 2024. Accessed April 7, 2025. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

5. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed April 7, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

6. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed April 7, 2025. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition