The next decade will reshape specialty drug spending, and the opportunity is enormous. As more than 100 biologic drugs lose patent protection through 2034, biosimilars – lower-cost alternatives to those treatments for serious and chronic diseases – could open the door to a potential $232 billion in savings. For employer’s pharmacy benefits plans, that possibility represents meaningful budget relief if new, lower cost options become available for the drugs driving their high-cost trend.
Here’s what you need to know: the biosimilar pipeline is moving fast, the regulatory environment is shifting, and the barriers slowing adoption are real but beatable. If benefits advisors can help position their clients ahead of these changes now, they could turn a looming patent cliff into a durable cost-savings strategy.
1. The Pipeline is a Once-in-a-Decade Opportunity
Biologics account for roughly 5% of prescriptions but 51% of drug spending, per the U.S. Food and Drug Administration (FDA). When a blockbuster biologic loses exclusivity, a lower-cost biosimilar can enter the market, sometimes cutting net cost significantly without compromising clinical value.
The scale here is different from anything the market has seen. As of July, the FDA had approved 89 biosimilars, and the coming wave targets the highest-cost categories in many clients’ plans. The takeaway is that the drugs losing protection aren’t niche products. They’re the ones inflating your clients’ specialty spend and trend today.
2. These are the High-Impact Drugs to Watch by Therapeutic Area
Not every loss of exclusivity (LOE) carries the same weight. Here’s a curated look at drugs worth watching, organized by therapeutic area.
Immunology:
Immunology is the single biggest driver of specialty trend for most employer plans, which makes it the category where biosimilar competition will hit hardest and fastest. These drugs treat chronic conditions, so members stay on them for years, and every dollar of net-cost reduction compounds across your book of business. The timing matters because several drugs are hitting their cliffs within the same narrow window, giving plan sponsors a rare chance to capture savings across multiple high-cost claims at once. Advisors who map these dates early can lock in tier placement and formulary strategy before rebate contracts try to hold reference products in place.
Six major products approaching their cliffs include:
- Treatments for plaque psoriasis:
- Cosentyx (secukinumab): $10.5 billion in 2025 sales, LOE January 2029
- Enbrel (etanercept): $4.7 billion in 2025 sales, LOE April 2029
- Treatments for psoriatic arthritis/rheumatoid arthritis:
- Orencia (abatacept): $5.6 billion in 2025 sales, LOE window of 2026-2028
- Cimzia (certolizumab): $4.4 billion in 2025 sales, LOE in 2029
- Simponi (golimumab): $825 million in 2025 sales, LOE Q4 2026
- Treatments for ulcerative colitis:
- Entyvio (vedolizumab): $6.2 billion in 2025 sales, LOE window of 2027 to 2033
With multiple manufacturers already in final-stage clinical trials for a Cosentyx biosimilar, this is a category to build strategy around now.
Oncology:
Oncology carries a different kind of urgency for plan sponsors. Cancer claims are among the most catastrophic and least predictable expenses a plan can face, so any tool that lowers the cost of frontline therapies directly reduces exposure to budget-busting claims. The presence of multiple manufacturers racing toward the same LOE signals aggressive price competition, which typically translates to steeper discounts the moment biosimilars launch. For advisors, that means the potential to protect a client’s plan against one of its highest-risk categories while preserving the precise clinical outcomes members depend on.
Here’s what’s on the horizon in terms of likely new biosimilar activity::
- Treatment for non-small cell lung cancer (NSLC), melanoma, urothelial cancer, colorectal cancer, and other cancers:
- Keytruda (pembrolizumab): $22.4 billion in 2025 sales, LOE 2028 to 2029, with five manufacturers in Phase 3
- Opdivo (nivolumab): $7.1 billion in sales, LOE December 2028
A biosimilar for Keytruda alone could meaningfully shift oncology spend across a book of business.
Pulmonology and Endocrinology:
These two categories round out the near-term picture, and they matter because their cliffs arrive sooner than the rest. Xolair and Trulicity treat large, growing populations, so even modest per-script savings scale quickly across a plan’s membership. Diabetes and respiratory conditions are also chronic, meaning members refill month after month and the savings recur rather than appearing once.
Key takeaway: Map your clients’ current spend against these LOE dates. The advisors who plan two to three years ahead will capture savings the moment biosimilars launch.
3. The FDA is Clearing the Path Faster Than Ever
Regulators are actively clearing the path. In March, the FDA issued draft guidance recommending removal of certain clinical testing requirements when existing evidence already supports the development of biosimilars. That change could cut study costs by up to 50%, roughly $20 million per development program.
The agency had already scaled back comparative efficacy study expectations, which can run one to three years and cost about $24 million. It also updated guidance on non-U.S.-licensed comparator products, giving developers more flexibility.
More efficient approvals mean more market entrants. For your clients, that translates to better pricing, strong negotiating leverage, and broader formulary options.
4. Four Barriers Still Slow Adoption, and Each One is Beatable
Savings won’t happen automatically. Four obstacles continue to hold biosimilars back, and each requires a deliberate response.
- Complex formulary structures. Rebate contracts often keep reference biologics in preferred positions, leaving biosimilars with unfavorable tier placement and higher member cost sharing.
- The high WAC pricing paradox. Manufacturers may set a high wholesale acquisition cost (WAC) at launch to recover development investment, which undercuts the affordability promise and limits early uptake.
- Patent thickets and pay-for-delay tactics. AbbVie protected Humira with more than 200 patents, delaying biosimilar competition for seven years after the core patent expired. Litigation alone can push market entry back two years or more.
- Prescriber and patient hesitancy. Without clear guidance on safety, efficacy, and interchangeability, both groups may view biosimilars as unproven. That hesitation is not new. Generics faced similar resistance during their early adoption years, but confidence grew as education, familiarity, and real-world use reinforced their value.
These barriers are addressable, but only if advisors name them early and build strategies to work around them.
What Advisors Should Do Now
Your clients look to you to convert this pipeline into results. Focus on these core actions to help:
- Update formularies proactively: Prefer clinically appropriate biosimilars the moment they deliver equal outcomes at lower total cost.
- Push for biosimilar-preferred tiering: Advocate for placement that lowers member cost sharing rather than protecting rebate-rich brands.
- Demand net-cost transparency: Insist on a clear view of wholesale costs, rebates, fees, and net spend so formulary decisions rest on true value, not gross rebates.
- Educate clients and stakeholders: Clear communication about biosimilar safety and interchangeability reduces hesitation and speeds adoption.
The biosimilar pipeline represents one of the largest cost-savings opportunities in specialty pharmacy. If you pull your clients’ specialty spend, match it against the LOE dates, and start the formulary conversation now, you will provide important value. The advisors who prepare today will deliver savings the day these biosimilars launch.
Learn more:
10 Most Expensive Drugs in the U.S.: 2026 Edition, July 21, 2026
3 Warning Signs That You’re Overpaying for Specialty Drugs, June 23, 2026
The Employer’s GLP-1 Dilemma: Balancing Quality Care and Cost Control, April 22, 2026
