Specialty Pharmacy and Generics: Key Practice Challenges and Strategies

When a patient with multiple sclerosis starts on a drug that costs over $78,000 a year, the pharmacy team doesn’t just fill a prescription-they manage a lifelong treatment plan. That’s the reality of specialty pharmacy. Unlike your local drugstore, where 90% of prescriptions are generics, specialty pharmacies handle high-cost, complex medications for chronic conditions like cancer, rheumatoid arthritis, and hepatitis C. These aren’t pills you pick up on the way home. They’re injectables, infusions, and biologics that need refrigeration, special handling, and constant monitoring. And now, as generics and biosimilars enter this space, the job is getting even more complicated.

What Makes Specialty Drugs Different?

Specialty drugs aren’t just expensive-they’re complex. Most are biologics, meaning they’re made from living cells, not synthesized in a lab like traditional pills. This makes them harder to copy. A brand-name drug like Humira costs around $7,000 a month. Its biosimilar, adalimumab-atto, might cost 30% less-but that’s still $4,900. Meanwhile, a generic version of a traditional drug like metformin costs pennies. The difference isn’t just price. Specialty drugs require strict storage (2-8°C), specialized administration (subcutaneous injections, IV infusions), and frequent lab tests to track effectiveness and safety.

These drugs also come with heavy administrative burdens. Before a patient can get one, the pharmacy must get prior authorization from the insurance plan. That means filling out forms, submitting lab results, and sometimes arguing with a Pharmacy Benefit Manager (PBM) who’s more focused on cost than care. And even after approval, reimbursement is often below what the pharmacy paid for the drug. According to Frier Levitt (2023), some PBMs reimburse specialty pharmacies less than acquisition cost-meaning the pharmacy loses money on every prescription.

Generics in Specialty Pharmacy: Not as Simple as It Sounds

For most community pharmacies, switching to a generic is routine. The patient gets the same active ingredient, cheaper price, and a different-looking pill. But in specialty pharmacy, it’s not that simple. Most specialty drugs still don’t have generics. Why? Because biologics are too complex to replicate exactly. That’s why we have biosimilars-drugs that are highly similar to the original, but not identical. The FDA approved its first interchangeable biosimilar, Semglee (for insulin glargine), in 2021. Since then, over 35 biosimilars have been approved, with more on the way as patents expire on big-name drugs like Humira and Enbrel.

But here’s the catch: even when generics exist for specialty drugs, they’re not always easy to use. Take glatiramer acetate (Copaxone). When the generic version hit the market in 2021, the annual cost dropped from $78,000 to $45,000. That’s a huge savings. But patients started reporting new side effects after switching. Why? Because while the active ingredient is the same, the inactive ingredients-fillers, preservatives, stabilizers-can differ between manufacturers. For a patient stabilized on one brand, even small changes can trigger a flare-up.

The Narrow Therapeutic Index Problem

Some drugs have what’s called a narrow therapeutic index (NTI). That means the difference between an effective dose and a toxic one is tiny. Levothyroxine, used for hypothyroidism, is one. Warfarin, a blood thinner, is another. For these, even a 5% change in blood levels can cause serious problems-either the drug doesn’t work, or it causes bleeding. The FDA says generics are bioequivalent, but real-world data tells a different story. Reddit threads from the r/pharmacy community in 2023 are full of patients describing fatigue, heart palpitations, or weight gain after switching from one generic manufacturer to another. One patient wrote: “My endocrinologist says they’re all the same. But I felt awful for three weeks after the switch. I went back to the brand, and I’m fine.”

Specialty pharmacists know this. That’s why many avoid switching patients on NTI drugs unless absolutely necessary. If a patient is stable on a brand, switching to a generic-even if it’s cheaper-can do more harm than good. The American Society of Health-System Pharmacists (ASHP) recommends documenting patient-specific reasons to avoid substitution, like previous adverse reactions or sensitivity to excipients. But few pharmacies have systems in place to track this across multiple manufacturers.

Operational Nightmares: PBMs, Tracking, and Patient Confusion

One of the biggest headaches for specialty pharmacies isn’t clinical-it’s administrative. PBMs often track something called the Generic Dispensing Ratio (GDR). They expect pharmacies to dispense a certain percentage of generics. But if your pharmacy only handles drugs with no generic version-like most biologics-you’re stuck. You can’t hit the target. And some PBMs penalize you for it. That’s like being fined for not selling apples when you only sell oranges.

Then there’s inventory. When a generic becomes available, it’s not just one product-it’s five. Different manufacturers, different packaging, different labels. One pharmacy in Toronto reported managing seven different versions of the same generic glatiramer acetate. Each has its own lot number, expiration date, and storage requirement. Staff spend hours just tracking which vial came from which supplier. And when a patient calls, confused because their pill looks different, the pharmacist has to explain: “It’s the same drug, just made by a different company.”

A 2022 survey in Specialty Pharmacy Times found that 78% of specialty pharmacy staff listed “managing patient concerns about generic substitutions” as a major workflow challenge. Another 65% said tracking multiple manufacturers was a burden. These aren’t minor issues. They eat up time, increase stress, and can lead to errors.

How to Do It Right: Best Practices for Specialty Pharmacists

So how do you navigate this? It’s not about avoiding generics. It’s about using them wisely.

• Start with your top therapies. Focus on the drugs your patients use most. If 40% of your caseload is on MS medications, prioritize generics for those first.
• Standardize. Pick one manufacturer for each generic product. Don’t juggle five suppliers. Consistency reduces confusion and makes inventory easier.
• Document exceptions. If a patient has had a reaction to a generic before, or has an excipient allergy, flag it in their record. Don’t rely on memory.
• Monitor after the switch. For NTI drugs or biologics, schedule follow-up labs or calls within 30 days. Ask: “How are you feeling?” “Any new side effects?”
• Educate, don’t assume. Don’t tell patients “it’s the same.” Say: “This is a different version of the same medicine. It’s cheaper, and the FDA says it works the same. But we’re going to check in with you to make sure you’re doing okay.”

McKesson Medical-Surgical recommends partnering with a single distributor for generics to avoid supply chain chaos. That’s smart. If you’re buying from three different suppliers, you’re buying three different risks.

The Future: Biosimilars Are Coming-Are You Ready?

The biggest shift in specialty pharmacy isn’t just generics-it’s biosimilars. These aren’t small-molecule copies. They’re complex, living-molecule versions of biologics. And they come with their own rules. Unlike generics, which can be automatically substituted in some states, biosimilars require prescriber approval for substitution. Interchangeable biosimilars-like Semglee-can be swapped without a new prescription, but only if the pharmacy and prescriber agree.

Right now, adoption is slow. Why? PBMs still favor the brand. They get rebates from manufacturers that make the brand cheaper for the plan-even if the biosimilar is less expensive for the patient. And patients are scared. Many think “biosimilar” means “inferior.” That’s not true. The FDA requires biosimilars to show no clinically meaningful differences in safety or effectiveness. But that’s not what patients hear.

Specialty pharmacies are on the front lines of changing that. Your job now isn’t just dispensing. It’s educating. It’s explaining why a biosimilar isn’t a cheap knockoff-it’s a scientifically validated alternative. It’s helping patients understand that switching doesn’t mean lowering the standard of care.

The Congressional Budget Office estimates biosimilars could save the U.S. healthcare system $54 billion over the next decade. That’s real money. But it won’t happen unless pharmacists step up.

Final Thought: It’s About Care, Not Just Cost

Specialty pharmacy was created to help patients with complex, life-altering conditions. That mission hasn’t changed. Generics and biosimilars aren’t enemies-they’re tools. But tools need skill to use well. You can’t just swap a pill and walk away. You have to track, monitor, educate, and advocate. You have to push back when PBMs make unreasonable demands. You have to protect patients from unnecessary switches. And you have to make sure cost savings don’t come at the cost of safety.

That’s the unique practice consideration no one talks about enough: in specialty pharmacy, the right decision isn’t always the cheapest one. It’s the one that keeps the patient stable, informed, and safe.