Specialty Pharmacy and Generics: Unique Practice Considerations for Pharmacists

When a patient with multiple sclerosis switches from a $78,000-a-year brand-name drug to a $45,000 generic version, the savings are clear. But what happens when that same patient starts feeling dizzy, fatigued, or worse-after the pill looks different, tastes different, or comes in a new bottle? This isn’t a rare scenario. It’s everyday reality in specialty pharmacy, where the line between cost-saving and clinical risk is razor-thin.

What Makes Specialty Pharmacy Different

Specialty pharmacy isn’t just about expensive drugs. It’s about complex therapies for chronic, life-altering conditions: cancer, rheumatoid arthritis, hepatitis C, HIV, and multiple sclerosis. These medications are often biologics-large, intricate molecules made from living cells. They require cold storage (2-8°C), specialized administration (injections or infusions), and constant monitoring. Unlike a statin or a blood pressure pill you pick up at your local pharmacy, specialty drugs demand ongoing care coordination, patient education, and tracking of side effects.

Most of these drugs were, until recently, only available as brand-name products. But that’s changing. Patents are expiring. Biosimilars-generic-like versions of biologics-are entering the market. The FDA approved its 35th biosimilar in December 2023. And with them comes a new set of challenges for pharmacists who’ve never had to manage this kind of complexity before.

Generics in Specialty: Not All Are Created Equal

The FDA says generics must be bioequivalent to their brand-name counterparts. That means they deliver the same active ingredient, in the same amount, at the same rate. Sounds simple. But in specialty pharmacy, that’s not the whole story.

For drugs with a narrow therapeutic index (NTI)-where even tiny changes in blood levels can cause toxicity or treatment failure-switching between brands or between different generic manufacturers can be risky. Levothyroxine, for example, is a small-molecule NTI drug. Patients on it often report symptoms when switched between generic brands, even though the FDA says they’re interchangeable. Reddit threads from the r/pharmacy community are full of patients describing sudden weight gain, heart palpitations, or depression after a switch.

The issue isn’t always the active ingredient. It’s the excipients-the inactive fillers, dyes, and binders. One generic version of a specialty drug might use lactose. Another might use corn starch. For a patient with a rare allergy or sensitivity, that difference matters. Specialty pharmacies must track these details, not just the drug name.

The PBM Problem

Pharmacy Benefit Managers (PBMs) control reimbursement. They set the prices pharmacies get paid. And they’re pushing hard for higher Generic Dispensing Ratios (GDR)-the percentage of prescriptions filled as generics.

Here’s the catch: many specialty drugs don’t have generics. Yet PBMs still penalize specialty pharmacies that don’t meet GDR targets. Imagine a clinic treating 50 patients with a rare autoimmune disease. None of their drugs have generic alternatives. But the PBM still demands a 70% generic rate. The pharmacy gets fined. The patient gets confused. The pharmacist has to spend hours justifying why they can’t fill a non-generic drug with a generic that doesn’t exist.

And when generics do become available, PBMs often force substitutions without consulting the prescriber or patient. One specialty pharmacy in Ohio reported a 40% drop in patient adherence after being required to switch 12 patients from a stable brand-name drug to a new generic. Three patients were hospitalized within six weeks.

Biosimilars: The Next Frontier

Biosimilars aren’t true generics. They’re not exact copies. Because biologics are made from living cells, no two batches are identical-even from the same manufacturer. A biosimilar must be highly similar, but not identical. That’s why the FDA requires extra testing.

The first interchangeable biosimilar-Semglee for insulin glargine-was approved in 2021. That means pharmacists can swap it in without asking the doctor. But that’s not the case for most others. For drugs like Humira, biosimilars launched in 2023 after years of legal battles. Now, pharmacists have to know which ones are interchangeable, which aren’t, and which require a new prescription.

The promise? Up to $54 billion in savings over the next decade, according to the Congressional Budget Office. The reality? Many PBMs still place biosimilars on high-tier formularies, making patients pay more out-of-pocket than for the brand-name drug. Why? Because the brand still pays bigger rebates. So even when a cheaper, equally effective option exists, the system still pushes the more expensive one.

What Pharmacists Can Do

Specialty pharmacists aren’t just dispensers. They’re care coordinators. Here’s how to handle generics and biosimilars effectively:

• Know your top therapies. Focus on the 5-10 most common specialty drugs in your practice. Map out which have generics or biosimilars, and which don’t.
• Standardize your inventory. Don’t stock every generic version of a drug. Pick one preferred manufacturer per product, based on reliability, patient feedback, and cost. This cuts down on confusion and errors.
• Document patient-specific risks. If a patient has had a reaction to a specific excipient, record it. Flag it in your system. Don’t assume all generics are safe for everyone.
• Monitor after substitution. For NTI drugs or biosimilars, schedule follow-ups within 30 days. Check labs. Ask how they’re feeling. Don’t wait for them to call you.
• Educate patients upfront. If a drug changes appearance, explain why. Show them the new label. Tell them it’s the same medicine, just made by a different company. Many patients think they’re getting a weaker version.

The Human Side of the Switch

A 2022 survey of specialty pharmacy staff found that 78% said managing patient concerns about generic substitutions was a major workflow burden. Patients don’t trust change. They’ve been on the same brand for years. They’ve seen their disease stabilize. Now, they’re being told to try something new-something that looks different, costs less, and might not work the same.

One woman with rheumatoid arthritis told her pharmacist: “I’ve been on this drug for eight years. My joints don’t hurt. Why are you giving me a different pill?” She wasn’t resisting because she didn’t understand. She was resisting because she’d been told, over and over, that this drug saved her life. And now, someone was trying to take that away.

That’s where the pharmacist’s role becomes critical. It’s not about pushing cost savings. It’s about building trust. It’s about saying: “I hear you. Let’s make sure this change is safe for you.”

Future Challenges

The number of specialty drugs with generics or biosimilars will keep growing. Humira biosimilars are just the beginning. More than 20 biologics are set to lose patent protection by 2030. That means more switches, more confusion, more risk.

Specialty pharmacies will need better systems to track manufacturers, manage inventory, and flag at-risk patients. They’ll need clearer guidelines from PBMs and regulators. And most of all, they’ll need time-to talk to patients, to monitor outcomes, to make sure that savings don’t come at the cost of safety.

The goal isn’t to eliminate brand-name drugs. It’s to use generics and biosimilars wisely-when they’re safe, when they’re appropriate, and when the patient is ready.