Specialty Pharmacy and Generics: Unique Practice Considerations for Pharmacists

Specialty pharmacy isn’t just another pharmacy

When you walk into a community pharmacy, you’re used to seeing shelves full of pills-ibuprofen, metformin, lisinopril-all cheap, easy to stock, and often generic. But specialty pharmacies? They’re a different world. These aren’t your run-of-the-mill drug outlets. They handle medications that cost thousands per month, need refrigeration, require injections or infusions, and are used for life-altering conditions like cancer, multiple sclerosis, or rheumatoid arthritis. And here’s the twist: while generics have transformed how we think about everyday prescriptions, they’ve made specialty pharmacy way more complicated-not simpler.

Why specialty drugs are so expensive-and why generics matter

Specialty medications aren’t just pricey because they’re complex. They’re expensive because they’re biologics: large, intricate molecules made from living cells. Think of them like a hand-sculpted statue versus a mass-produced plastic toy. The cost? Often over $1,000 a month. A single course of treatment for some autoimmune diseases can hit $100,000 a year. That’s why when a generic version finally arrives, it’s a game-changer.

Take Copaxone, a drug for multiple sclerosis. Before its generic version came out, patients paid around $78,000 annually. After the generic glatiramer acetate hit the market, the price dropped to $45,000. That’s still steep, but it’s a 42% cut. And that’s not rare. Generic drugs, on average, cost 80-85% less than their brand-name equivalents. For specialty pharmacies, that’s not just a savings-it’s a lifeline for patients who can’t afford treatment.

Generics aren’t always interchangeable-especially in specialty care

Here’s where things get tricky. The FDA says generics are bioequivalent to brand drugs. That means they deliver the same active ingredient at the same rate and amount. Sounds perfect, right? But in specialty pharmacy, bioequivalence doesn’t always mean clinical equivalence.

For drugs with a narrow therapeutic index (NTI)-like levothyroxine, warfarin, or some epilepsy meds-tiny differences in blood levels can mean the difference between control and crisis. Patients who’ve been stable on a brand drug for years can start having seizures, thyroid spikes, or dangerous clots after switching to a different generic manufacturer. Why? Because inactive ingredients (excipients) change. The pill might look different. The coating might dissolve faster. The filler might trigger an allergy.

One 2022 survey of specialty pharmacy staff found that 78% of them said managing patient concerns about generic substitutions was a major workflow headache. Patients show up confused: “This pill is blue now, not white. Did they give me the wrong drug?” Pharmacists have to explain that color doesn’t matter-but it’s still a battle.

Biosimilars: the next frontier

Generics for small-molecule drugs are one thing. But what about biologics? That’s where biosimilars come in. These aren’t exact copies-because you can’t copy a living cell like you copy a chemical formula. They’re highly similar versions, approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. As of December 2023, the FDA had approved 35 biosimilars.

Humira, the top-selling drug in the U.S. for years, finally got its first biosimilars in 2023 after years of patent battles. Now, instead of paying $20,000 a year for Humira, patients might pay $8,000 for an adalimumab biosimilar. That’s huge. But here’s the catch: biosimilars aren’t automatically interchangeable. Only one, Semglee (a biosimilar to insulin glargine), has been approved as “interchangeable” by the FDA-meaning a pharmacist can swap it without the prescriber’s OK, just like a regular generic.

For specialty pharmacies, this means new rules. You can’t just swap a biosimilar like you swap a generic. You need documentation. You need consent. You need to track which version the patient is on. And you need to educate them-because many still think “biosimilar” means “inferior.”

Pharmacy benefit managers are making it harder

It’s not just the science that’s complicated. It’s the money. Pharmacy Benefit Managers (PBMs) control which drugs get covered, how much they pay pharmacies, and what incentives they offer. Many PBMs set a Generic Dispensing Ratio (GDR)-a target for how many prescriptions should be filled with generics. Sounds fair? Not in specialty pharmacy.

Here’s the problem: if a specialty pharmacy doesn’t have a generic version of a drug, they still get penalized for not hitting the GDR. One pharmacy owner told me they were fined $12,000 last year because they didn’t dispense enough generics-despite the fact that 90% of their drugs had no generic alternative. PBMs don’t care. They measure the ratio, not the reality.

And reimbursement? It’s broken. Specialty pharmacies often buy drugs at $1,200 and get reimbursed $1,100 by the PBM. That’s a $100 loss per script. Meanwhile, community pharmacies make money on generics because they buy them cheap and sell them at a markup. Specialty pharmacies are stuck paying high prices and getting paid less. Some are going out of business.

What specialty pharmacies must do differently

If you run or work in a specialty pharmacy, here’s what you need to do differently than in a retail setting:

• Standardize your generics. Don’t stock five different brands of the same generic drug. Pick one that’s proven reliable, has consistent supply, and matches your patients’ needs. Complexity kills efficiency.
• Track excipients. If a patient has a known allergy to lactose, corn starch, or a dye, you need to know which generic version contains it. Build that into your system.
• Document substitution decisions. Never switch a patient on a narrow therapeutic index drug without a clear reason, documentation, and follow-up. Record the brand and generic name, date, and reason for change.
• Monitor after switch. For NTI drugs, check blood levels within 4-6 weeks after switching. Don’t assume it’s fine because the FDA says so.
• Educate patients. Use simple language: “This pill works the same way, but it’s made by a different company. It might look different, but it’s safe.”
• Work with one distributor. McKesson and others recommend sourcing generics from a single, reliable distributor. Jumping between suppliers adds administrative chaos and increases the risk of stockouts or errors.

The patient experience: confusion, fear, and hope

Patients don’t care about PBM policies or bioequivalence studies. They care if their pain is controlled, if they can breathe, if they can get out of bed. When their medication changes unexpectedly, they panic. Reddit threads are full of stories: “My tremors came back after switching generics.” “I got sick every time they changed the pill.”

But there’s hope. One 2014 study showed that with proper specialty pharmacy support-medication therapy management, home delivery, nurse calls-adherence to MS drugs jumped from 33% to 60%. That’s not just about the drug. It’s about the care around it.

When patients understand why a biosimilar is safe, when they’re involved in the decision, when their pharmacist takes time to explain, they’re more likely to stick with it. And that’s the real value of specialty pharmacy: not just dispensing drugs, but managing people.

The future: more biosimilars, more pressure, more responsibility

More blockbuster biologics are losing patents every year. Humira’s biosimilars are just the start. Enbrel, Remicade, and others will follow. By 2030, biosimilars could save the U.S. healthcare system over $50 billion.

But that only happens if specialty pharmacies are supported-not punished. PBMs need to stop penalizing pharmacies for not having generics that don’t exist. Regulators need to make interchangeable biosimilars easier to adopt. Pharmacists need better tools to track substitutions and communicate with patients.

The bottom line? Specialty pharmacy is no longer optional. It’s essential. And as generics and biosimilars grow, the role of the pharmacist is shifting from order filler to care coordinator. That’s not a burden. It’s the future.