When a patient walks into the pharmacy with a prescription for a biologic drug like Neulasta or Humira, they’re not just getting a pill-they’re getting a complex therapy that can cost thousands of dollars per month. That’s where pharmacists step in-not just to fill the script, but to guide the patient through one of the biggest shifts in modern medicine: the move from originator biologics to biosimilars.
What Makes Biosimilars Different from Generics?
People often assume biosimilars are just like generic drugs. They’re not. Generics are exact chemical copies of small-molecule drugs like atorvastatin or metformin. Biosimilars, on the other hand, are made from living cells-yeast, bacteria, or mammalian cells-and are highly similar to their reference biologic, but not identical. Even tiny differences in how they’re manufactured can affect structure, which is why the FDA requires extensive testing to prove they’re safe and effective. The FDA’s approval process for biosimilars is stricter than for generics. While generics only need to show bioequivalence, biosimilars must prove no clinically meaningful differences in safety, purity, or potency. That’s why a biosimilar for insulin or a monoclonal antibody isn’t just a cheaper version-it’s a scientifically validated alternative backed by real-world data.Interchangeable vs. Non-Interchangeable: What Pharmacists Need to Know
Not all biosimilars are created equal when it comes to substitution. The FDA has a special designation: interchangeable. An interchangeable biosimilar has met additional requirements, meaning a pharmacist can substitute it for the reference product without needing the prescriber’s approval-just like generics. As of late 2023, only a handful of biosimilars have received this status. For example, the pegfilgrastim biosimilar (a Neulasta alternative) became interchangeable in 2022. But most biosimilars on the market today are non-interchangeable. That means the prescriber must explicitly allow substitution, or the pharmacist must get permission before switching. This distinction matters. If a pharmacist substitutes a non-interchangeable biosimilar without consent, they could be breaking state law. Each state has its own rules. Some require the prescriber to sign off. Others let pharmacists switch automatically if the patient agrees. Pharmacists must know their state’s laws cold.Why Pharmacists Are the Key to Biosimilar Adoption
Biologics make up only 2% of prescriptions in the U.S., but they account for nearly half of all prescription drug spending. That’s a massive financial burden on patients and the system. Biosimilars can cut those costs by 15% to 35%-sometimes more. But cost alone doesn’t drive adoption. Patients and doctors are hesitant. Many think switching to a biosimilar means lower quality. Some believe biosimilars are untested. Others fear switching will cause side effects. That’s where pharmacists come in. Research from the American Society of Clinical Oncology shows that when pharmacists lead education efforts, biosimilar adoption jumps fast. At the US Oncology Network, after pharmacists took over substitution decisions and trained providers, biosimilar use for pegfilgrastim went from almost zero to over 80% in under a year. Pharmacists don’t just hand out pills. They explain the science. They answer questions. They document the switch. And they track outcomes.
How to Counsel Patients About Biosimilars
Patient counseling isn’t optional-it’s essential. A 2022 study found that patients are 21% more likely to stop taking their medication if the pill looks different after a switch. That’s why clear communication matters. Here’s what works:- Start with trust: "The FDA requires biosimilars to work just like the original drug. No meaningful differences in safety or effectiveness."
- Use analogies: "Think of it like two different brands of aspirin. They’re not made the same way, but they both relieve pain the same way."
- Address fears: "Switching between the original and biosimilar has been studied in thousands of patients. No increased risk of side effects."
- Explain traceability: "You’ll get a card with the batch number. If something happens, we can track exactly which version you took."
- Follow up: "Let’s check in next month. How are you feeling? Any new symptoms?"
Pharmacists vs. Doctors: Who Leads the Change?
Doctors often don’t know the latest biosimilar data. A 2022 study found that 79% of pharmacists had received continuing education on biosimilars, compared to just 43% of physicians. Pharmacists are more likely to recommend biosimilars-87% versus 62%. That gap creates tension. Some prescribers resist substitution. One doctor on Student Doctor Network complained that a pharmacist switched his patient’s Humira to a biosimilar without asking, and he got angry. The patient ended up discontinuing treatment. The solution? Collaboration. The US Oncology Network solved this by requiring all providers to complete mandatory biosimilar training and sign an acknowledgment form. Once doctors understood the process, interruptions dropped. No more last-minute calls asking, "Can I switch this?" Pharmacists aren’t replacing doctors. They’re supporting them. By handling substitution, pharmacists free up doctors to focus on patient care-not paperwork.
Real-World Barriers and How to Overcome Them
Even with strong science and good intent, barriers remain:- State laws vary: 48 states have biosimilar substitution laws, but rules differ. Some require patient consent. Others require prescriber approval. Know your state’s exact requirements.
- Rebate traps: Some pharmacy benefit managers (PBMs) still favor originator biologics because of rebates. Pharmacists should push back and advocate for formulary changes that prioritize cost-effective options.
- Billing confusion: 79% of pharmacists said they need more training on billing and reimbursement. Mixing up codes for reference products and biosimilars can lead to denied claims.
- Traceability gaps: If a patient has a reaction, the pharmacy must be able to report the exact batch number. That’s why documenting the product name and lot number in the EHR isn’t optional-it’s critical for safety.
What Pharmacists Should Do Today
You don’t need to wait for perfect conditions to make a difference. Here’s how to start now:- Learn your state’s substitution law. Check your state pharmacy board’s website. Know when you can substitute and what documentation is required.
- Identify which biosimilars in your inventory are interchangeable. Use the FDA’s Purple Book database. It’s free and updated weekly.
- Create a patient handout. Simple, one-page info sheets explaining biosimilars in plain language. Include the FDA’s "9 Things to Know" key points.
- Partner with prescribers. Offer to give a 10-minute lunch-and-learn to your local oncology or rheumatology clinics. Bring data. Show them the adoption numbers.
- Track your impact. Count how many biosimilar switches you make each month. Share that data with your pharmacy manager. Prove the value.
Why This Matters Beyond the Pharmacy Counter
Biosimilars aren’t just about saving money. They’re about access. Many patients skip biologic doses because they can’t afford them. With biosimilars, more people can get the treatment they need. Pharmacists are uniquely positioned to bridge the gap between science and patient care. We’re not just dispensers. We’re educators, advocates, and safety nets. The future of biologic therapy won’t be decided in boardrooms or by manufacturers. It will be decided in pharmacies, one conversation at a time.Can pharmacists substitute biosimilars without a doctor’s approval?
Only if the biosimilar has been designated as "interchangeable" by the FDA AND your state law allows automatic substitution. Most biosimilars are not interchangeable yet, so pharmacists usually need prescriber permission. Always check your state’s specific rules.
Are biosimilars as safe as the original biologic drugs?
Yes. The FDA requires biosimilars to show no clinically meaningful differences in safety, purity, or potency compared to the reference product. Thousands of patients have used biosimilars in the U.S. and Europe for over a decade with no increased risk of side effects. Switching between the original and biosimilar has been studied and found to be safe.
Why do some patients stop taking biosimilars after switching?
The most common reason is that the pill or injection looks different-different color, size, or packaging. Studies show patients are 21% more likely to discontinue use when they notice a change. Clear counseling about why the change happened and reassurance that it’s safe can prevent this.
Do pharmacists need special training to handle biosimilars?
Yes. Unlike generics, biosimilars require understanding of complex manufacturing, regulatory pathways, state substitution laws, and pharmacovigilance. Pharmacists should complete continuing education on biosimilars, especially on interchangeability, billing codes, and patient communication. Many pharmacy boards offer free or low-cost courses.
What should pharmacists document when substituting a biosimilar?
Pharmacists must record the name of the product dispensed (including the brand and generic name), the lot or batch number, and the date of substitution. This is critical for traceability in case of adverse events. The documentation should be in the patient’s electronic health record and shared with the prescriber if required by state law.
Are biosimilars cheaper than the original biologics?
Yes, typically by 15% to 35%, and sometimes more. However, rebate deals between drug manufacturers and pharmacy benefit managers can sometimes make the original product appear cheaper. Pharmacists should work with payers to ensure patients get the most cost-effective option, not just the one with the highest rebate.
