There are pharmaceutical trends that happen every year, and if you aren't keeping a close eye, you may miss key opportunities. Guided by decades of experience as generational pharmacists, the Health Strategists at True Rx firmly have our sights on key market events in 2025. Here's what we're watching:
Stelara® Biosimilars Expected
Under the brand name Stelara, ustekinumab is an immunosuppressant used to treat psoriatic arthritis, plaque psoriasis, Crohn’s Disease and ulcerative colitis. In 2025, the exclusivity period for Stelara is expiring and we anticipate at least five new biosimilar medications.
A biosimilar is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Just like generic medications, prescribers are increasingly willing to utilize lower-cost biosimilars, especially for inflammatory conditions, which is where we are primarily seeing competition.
Biosimilars introduce significant competition, which leads to price deflation and savings for employers and patients—2025 promises to be a year of savings opportunities in this high-impact category. See our Biosimilar white paper to learn more.
New Medication Class for Acute Pain
Opioid medications are highly effective for pain management but also have a substantial impact on society due to their side effects and the potential for addiction and abuse. Suzetrigine introduces a new drug class, the first for acute pain in over 20 years.
On January 30, Journavx (suzetrigine) was approved by the Federal Drug Administration (FDA). The short-term pain medication is designed to avoid the addictive properties associated with traditional opioid pain medications by targeting a specific pain pathway and is a very exciting development in pain management.
More GLP-1 Indications
Glucagon-like peptide-1 (GLP-1) medications such as Ozempic® and Wegovy® are, by now, well known for their role in treating diabetes and weight management. However, in 2025, we expect to see increased utilization of GLP-1 medications as they obtain additional FDA approval for other conditions such as sleep apnea, kidney disease, heart failure and metabolic dysfunction-associated steatohepatitis (MASH), a chronic liver disease.
In December 2024, the FDA approved Zepbound®, a GLP-1 receptor agonist, for the treatment of obstructive sleep apnea (OSA). This expands Zepbound’s indications, as it was initially approved for chronic weight management in adults with a weight-related comorbid condition.
Until now, positive airway pressure therapy (PAP) has been the only treatment for OSA, but the FDA’s decision means patients have another resource for treatment and relief from the symptoms of daytime fatigue and reduced alertness. OSA is the most common type of sleep apnea and an estimated 26 percent of Americans between the ages of 30 and 70 are affected by it. Uncontrolled OSA increases the risk of high blood pressure, heart arrhythmias, stroke, heart attack, diabetes, mental health conditions, and reduced life expectancy.
This adds another piece to the GLP-1 puzzle that employers must assess.
Moreover, based on increased research, we expect more GLP-1s to have expanded indications in 2025. This may include Victoza® (liraglutide) and Wegovy (semaglutide), both being considered for improvement of insulin sensitivity in patients with polycystic ovary syndrome (PCOS). They are also being studied for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (MASH).
New Rare Disease Medications
Medications are deemed “orphan drugs” if fewer than 200,000 individuals in the U.S. are diagnosed with the condition they treat. These medications are typically costly at over $100K in total annual cost. Many of these conditions have few or no other available, approved treatments. We anticipate that an increased number of orphan drugs will be approved by the FDA in 2025.
No one can fully predict what the future holds, as FDA approvals and medication developments are constantly evolving. However, based on the issues we’ve been tracking and our experiences as pharmacists and Health Strategists, we consider these to be among the top standout market events to watch in 2025.
Do you have questions about any of the anticipated standout market milestones and how they may affect your organization and employees? Reach out and connect with a Health Strategist.
Our clinically trained team members take a patient-first approach to health care and cost management, and we’re always ready to help.