Specialty Pharmacy and Generics: Key Practice Challenges and Opportunities

When you think of a pharmacy, you might picture a neighborhood store handing out pills for high blood pressure or antibiotics. But specialty pharmacy is a whole different world. These pharmacies handle drugs that cost thousands a month, need refrigeration, require injections or infusions, and treat serious, lifelong conditions like cancer, multiple sclerosis, and rheumatoid arthritis. And now, as more of these expensive drugs lose patent protection, generics and biosimilars are starting to enter the mix-bringing both savings and serious new challenges.

What Makes Specialty Pharmacy Different?

Specialty pharmacies don’t just fill prescriptions. They manage entire care journeys. A patient on a biologic for Crohn’s disease might need help with insurance approvals, training on how to self-inject, tracking side effects, and getting supplies delivered to their door. These drugs often cost over $1,000 a month. Some top-tier therapies can hit $78,000 a year. That’s not a typo.

Unlike your local CVS or Walgreens, where 90% of prescriptions are filled with generics, specialty pharmacies rarely have that option. For years, most of these drugs were biologics-complex proteins made from living cells. You can’t just copy them like a pill. That’s why, until recently, there were no true generics. But that’s changing fast.

Generics in Specialty: Not What You Think

When a small-molecule drug like metformin goes generic, it’s straightforward. Same active ingredient. Same pill shape. Same price-usually 80% cheaper. But when a specialty drug like Copaxone (glatiramer acetate) for multiple sclerosis went generic, the savings were huge: from $78,000 a year down to $45,000. That’s a win-for patients, for insurers, for the system.

But here’s the catch: not all generics are created equal. The FDA says they must be bioequivalent. That means they deliver the same amount of medicine into the bloodstream at the same rate. But that doesn’t mean they’re identical. The inactive ingredients-fillers, dyes, coatings-can change. A patient on a generic version of levothyroxine might switch from one manufacturer to another and suddenly feel fatigued, jittery, or gain weight. Why? Because even tiny differences in absorption can throw off thyroid levels in someone who’s finely tuned.

Specialty pharmacists know this. They’ve seen patients who’ve been stable for years on a brand-name drug, then get switched to a generic-and end up back in the hospital. It’s not common. But it’s common enough that many experts recommend avoiding switches for drugs with a narrow therapeutic index (NTI), where the difference between effective and toxic is razor-thin.

Biosimilars: The New Frontier

Biosimilars are the closest thing to generics for biologics. They’re not exact copies-because you can’t copy a living cell-but they’re highly similar, with no clinically meaningful differences in safety or effectiveness. The FDA approved its first interchangeable biosimilar, Semglee (for insulin glargine), in 2021. Since then, dozens more have come online, including biosimilars for Humira, Enbrel, and Remicade.

The potential savings? The Congressional Budget Office estimates biosimilars could save the U.S. healthcare system $54 billion over the next decade. That’s massive. But adoption is slow. Why?

First, patents. Big pharma has spent millions extending exclusivity through legal loopholes. Second, reimbursement. Pharmacy Benefit Managers (PBMs) often put biosimilars on higher cost tiers, forcing patients to pay more out-of-pocket. Third, education. Many doctors still don’t feel confident prescribing them. Patients are scared. “If it’s not the same brand, will it work?” is a common question.

Specialty pharmacies are on the front lines here. They’re the ones explaining to patients that a biosimilar isn’t a “cheap knockoff”-it’s a rigorously tested, FDA-approved alternative. They’re training nurses, updating protocols, and tracking outcomes.

Why Specialty Pharmacies Struggle with Generics

You’d think more generics would make life easier. But in specialty pharmacy, it’s the opposite.

Many PBMs measure a metric called the Generic Dispensing Ratio (GDR). If a specialty pharmacy doesn’t hit a certain GDR target-say, 70%-they get penalized. But here’s the problem: most specialty drugs still don’t have generics. So the pharmacy is being punished for doing the right thing-prescribing the only available, effective medication.

On top of that, sourcing generics for specialty drugs is messy. One manufacturer might supply glatiramer acetate in vials. Another in prefilled syringes. A third in a different color capsule. Inventory becomes a nightmare. A patient who’s been stable on one version gets switched to another-and panics because the pill looks different. Pharmacists spend hours reassuring them it’s the same drug.

A 2022 survey found that 78% of specialty pharmacy staff listed “managing patient concerns about generic substitutions” as a major workflow challenge. Sixty-five percent said tracking multiple manufacturers for the same product was a headache.

What Specialty Pharmacies Should Do

There’s no one-size-fits-all solution, but here’s what works:

• Start with your top therapies. Don’t try to switch everything. Focus on the most common, highest-cost drugs with available generics-like glatiramer acetate, interferons, or certain immunosuppressants.
• Standardize. Pick one generic manufacturer per drug, and stick with it. That cuts down on confusion, inventory chaos, and patient anxiety.
• Document exceptions. If a patient has an allergy to a specific excipient, or has had a bad reaction to a switch before, flag it in their record. Never auto-substitute.
• Monitor closely. For NTI drugs, check blood levels after a switch. Don’t assume bioequivalence means clinical equivalence.
• Educate patients upfront. Don’t wait for them to notice the pill changed. Explain it before the switch. Show them the FDA’s bioequivalence data. Use simple language: “This is the same medicine, just made by a different company. It’s been tested to work just as well.”

The Bigger Picture: Cost vs. Care

The push for generics in specialty pharmacy isn’t just about saving money. It’s about making life-changing treatments accessible. But cost can’t come at the cost of care.

One physician put it bluntly: “When it comes to generics, the primary consideration of managed care is cost.” And that’s the danger. If a PBM forces a switch without clinical input, or if a patient is scared off by a new pill shape and stops taking their drug altogether, the cost savings vanish-and the harm grows.

Specialty pharmacists aren’t just dispensers. They’re care coordinators. They’re patient advocates. They’re the ones who catch the warning signs when a switch goes wrong.

The future of specialty pharmacy isn’t about rejecting generics. It’s about using them wisely. With clear policies, strong patient communication, and a commitment to safety, generics and biosimilars can be powerful tools. But only if the system lets pharmacists do their job-not just fill prescriptions, but protect lives.

What’s Next?

More biosimilars are coming. Humira’s biosimilars launched in 2023. Others for Enbrel, Stelara, and Rituxan are on the horizon. The pipeline is full. But without changes in reimbursement, formulary design, and provider education, adoption will stall.

Specialty pharmacies need better support-not penalties-for not having generics. They need stable supply chains. They need time to counsel patients. And they need to be part of the decision-making, not just the last step in a cost-cutting algorithm.

The goal isn’t to replace brand drugs with generics. It’s to replace expensive, unaffordable drugs with safe, effective, affordable alternatives-without sacrificing outcomes. That’s the real challenge. And that’s where specialty pharmacy has its most important role to play.