Specialty Pharmacy and Generics: Key Practice Challenges and Strategies

When a patient with multiple sclerosis starts a new treatment, they don’t just get a prescription-they get a whole support system. That’s the reality of specialty pharmacy. These pharmacies handle high-cost, complex drugs for chronic conditions like cancer, rheumatoid arthritis, and hepatitis C. Many of these drugs are biologics: large, delicate molecules that need cold storage, special handling, and close monitoring. But here’s the twist: as patents expire, generics and biosimilars are creeping into this high-stakes space. And that’s where things get complicated.

What Makes Specialty Pharmacy Different?

Specialty pharmacy isn’t just about dispensing pills. It’s about managing entire treatment journeys. These medications often cost over $1,000 a month. Some exceed $100,000 a year. Unlike a typical statin or blood pressure pill, they’re not picked up off a shelf. They’re shipped with ice packs, tracked through supply chains, and accompanied by nurse calls, adherence programs, and lab monitoring.

The FDA requires brand-name specialty drugs to go through years of clinical trials before approval. But when generics enter the picture, the rules change. For small-molecule drugs, generics must prove bioequivalence-meaning they deliver the same active ingredient at the same rate and extent as the brand. That’s straightforward for a pill like metformin. But for a biologic like Humira? That’s not possible. Instead, we get biosimilars.

Biosimilars aren’t exact copies. They’re highly similar versions of complex biologic drugs, made from living cells. The FDA approved its first interchangeable biosimilar, Semglee (for insulin glargine), in 2021. By December 2023, 35 biosimilars had been approved. But approval doesn’t mean adoption. Many patients and providers still hesitate.

Why Generics Don’t Always Fit in Specialty Pharmacy

In a regular pharmacy, 90% of prescriptions are filled with generics. That’s the norm. In specialty pharmacy? It’s often less than 10%. Why? Because most specialty drugs still have no generic alternative. Even when one exists, switching isn’t automatic.

Take Copaxone, a drug for multiple sclerosis. When its generic version, glatiramer acetate, hit the market, the annual cost dropped from $78,000 to $45,000. That’s a huge savings. But many clinics didn’t switch immediately. Why? Because patients were stable. Changing the medication-even to an FDA-approved generic-could trigger unpredictable side effects. For drugs with a narrow therapeutic index (NTI), like levothyroxine or warfarin, even tiny differences in absorption can cause harm.

Patients have reported confusion and anxiety when their medication changes color, shape, or size. One Reddit user wrote about switching from one generic levothyroxine to another and developing palpitations. Their pharmacist assured them it was bioequivalent. But bioequivalence doesn’t always mean identical patient experience. Inactive ingredients-fillers, dyes, coatings-can vary. For someone with a rare allergy or sensitivity, that matters.

The PBM Problem: When Cost-Cutting Backfires

Pharmacy Benefit Managers (PBMs) control most specialty drug reimbursement. They set prices, determine formularies, and track metrics like the Generic Dispensing Ratio (GDR). Here’s the catch: PBMs often penalize specialty pharmacies for not hitting GDR targets-even when no generic exists for the drug being dispensed.

Imagine a specialty pharmacy that fills 100 prescriptions for a biologic with no generic version. The PBM still expects them to hit a 70% GDR. They don’t. The pharmacy gets fined. This creates a perverse incentive: pharmacies might avoid stocking drugs with no generics, even if those are the only options for patients. Or worse, they might pressure providers to switch patients to generics even when it’s not clinically safe.

A 2023 survey from Specialty Pharmacy Times found that 65% of specialty pharmacy staff struggle with tracking multiple manufacturers of the same generic drug. Why? Because PBMs often push the cheapest version, regardless of consistency. One patient might get a generic from Manufacturer A this month, Manufacturer B next month. Their body adapts. Then the switch happens again. Side effects appear. The patient blames the drug. The provider blames the pharmacy. The PBM blames the patient.

How Specialty Pharmacies Should Handle Generics

There’s a better way. It starts with policy.

First, don’t assume all generics are equal. Build a preferred list based on evidence, patient outcomes, and supplier reliability. Don’t just pick the lowest price. Pick the one with the fewest complaints, the most consistent supply, and the best documentation.

Second, document everything. If a patient has had a reaction to a specific generic manufacturer in the past, flag it in their record. If they’re on a stable dose of a biologic, don’t switch unless there’s a clear clinical benefit. For NTI drugs, consider holding off on substitution until the patient has been on the same version for at least 6 months.

Third, train your team. Staff need to know how to explain biosimilars to patients. They need to recognize when a patient’s anxiety about a pill change is real-even if the science says it shouldn’t matter. A 2022 study found that 78% of specialty pharmacy staff cited patient concerns about generic substitution as a major workflow challenge. That’s not just a communication issue. It’s a trust issue.

Fourth, partner with reliable distributors. McKesson Medical-Surgical recommends sourcing generics from a single, trusted distributor to avoid supply chain chaos. Mixing suppliers means more inventory errors, more labeling confusion, and more patient complaints.

Biosimilars: The Next Frontier

Biosimilars are the future of specialty pharmacy. But they’re not generics. They’re more like the next-generation version of a biologic. They’re complex. They require different handling. And their substitution rules vary by state and payer.

In some states, pharmacists can substitute a biosimilar for its reference product without the prescriber’s permission-if it’s labeled as “interchangeable.” Semglee is one. But not all biosimilars have that designation. And even when they do, many prescribers still require explicit approval.

The Congressional Budget Office estimates biosimilars could save the U.S. healthcare system $54 billion over the next decade. But savings won’t happen unless patients and providers trust them. That’s where specialty pharmacies come in. They’re the bridge between the science and the patient.

Educate. Don’t assume. Use visual aids. Show patients the FDA’s biosimilar approval process. Explain that while the molecule isn’t identical, the clinical outcomes are proven to be the same. And never, ever treat a biosimilar like a discount brand-name drug.

What’s Next for Specialty Pharmacy?

More biosimilars are coming. Humira’s first biosimilars launched in 2023 after years of patent battles. Others will follow. The market for specialty drugs is growing fast-they make up just 2% of prescriptions but nearly half of all drug spending.

Specialty pharmacies that survive will be the ones that stop treating generics like commodities. They’ll start treating them like clinical decisions. They’ll build systems to track manufacturer changes. They’ll train staff to have honest conversations with patients. They’ll push back on PBMs that demand unrealistic generic rates.

It’s not about choosing brand over generic. It’s about choosing the right drug for the right patient at the right time. And that’s what specialty pharmacy was always meant to be.