CASP Module 25, Section 2: Biosimilar and Biologic Market Evolution
MODULE 25: YOUR GUIDE TO THE GLOBAL & FUTURE LANDSCAPE

Section 25.2: Biosimilar and Biologic Market Evolution

Examining the impact of biosimilar introductions on market dynamics, pricing pressures, interchangeability challenges, provider and patient acceptance, and the evolving role of the HSSP.

SECTION 25.2

Biosimilar and Biologic Market Evolution

From Clinical Gatekeeper to Enterprise Portfolio Manager: The HSSP’s Role in the Multi-Billion Dollar Biologic Shift.

25.2.1 The “Why”: More Than Just a “Generic Biologic”

In your pharmacy career, no single market force will have a greater financial and operational impact on your practice than the rise of biosimilars. The “patent cliff” for small-molecule drugs (like Lipitor or Plavix) was a singular event. The shift to biosimilars is not a cliff; it’s a new, permanent tectonic plate in the landscape of medicine. For the next two decades, the most expensive, most complex, and most widely used drugs in your health system’s formulary will one by one face biosimilar competition. We are talking about hundreds of billions of dollars in enterprise-wide spend.

For the community pharmacist, a generic substitution is a simple, daily transaction. For the Health System Specialty Pharmacist (HSSP), a biosimilar conversion is a complex, high-stakes strategic enterprise project. It is not “if” your health system will adopt biosimilars; it is how, when, and which one(s). The answer to those questions will be shaped, and in many cases, led, by you.

Why is this your responsibility?

  • Financial Stewardship: You are the steward of your health system’s drug budget. A successful biosimilar strategy for a single drug like adalimumab can save your institution tens of millions of dollars annually. That is money that can be used to fund new provider positions, expand clinics, or absorb uncompensated care.
  • Clinical Confidence: You are the only one on the P&T committee, in the clinic, or in the administration who truly understands the science. You are the one who can read the FDA’s “totality of the evidence” and explain to a skeptical provider why this new drug is not a “cheap knock-off” and why “extrapolation of indications” is sound science.
  • Operational Complexity: You are the hub of the operational wheel. A “simple” formulary switch from one biologic to one biosimilar involves updating EMR order sets, managing inventory (inpatient, outpatient, 340B), coordinating with payers, and re-educating thousands of patients and hundreds of providers. This is an implementation science project, and you are the project manager.
  • Patient Safety & Acceptance: You are the antidote to the “nocebo” effect. Your high-touch, trusted relationship with the patient is the single most important factor in ensuring a smooth clinical transition and maintaining adherence.

This section is not an academic review. It is a leadership playbook. We will deconstruct the science, the terminology, the market dynamics, and the clinical controversies. But most importantly, we will provide you with the scripts, strategies, and step-by-step guides you need to lead this evolution in your own health system. Your expertise here doesn’t just make you a good pharmacist; it makes you an indispensable strategic asset to your organization’s C-suite.

Pharmacist Analogy: The Global Winery

This analogy is the most critical one to master. You must be able to explain the difference between a small molecule, a generic, and a biosimilar in 30 seconds.

1. Small-Molecule Drug (e.g., Atorvastatin):
This is a simple chemical, like a molecule of pure, synthetic caffeine. It’s made in a lab through a predictable, repeatable chemical synthesis. It has a 100% defined structure.

2. Generic Drug (e.g., generic Atorvastatin):
This is another batch of pure, synthetic caffeine. Because the chemical formula is simple and known, any lab can follow the recipe and produce the exact same identical molecule. The FDA just has to confirm your batch is 100% pure caffeine (bioequivalence). It is chemically identical.

3. Biologic (Reference Product, e.g., Humira):
This is not a simple chemical. It is a complex vintage of wine (a protein), grown and harvested in a unique, proprietary, living system (a genetically engineered Chinese Hamster Ovary, or CHO, cell line). The final “wine” (the adalimumab molecule) is massive—thousands of times larger than caffeine. Its final taste and quality are sensitive to the soil (cell media), the weather (bioreactor temperature), and the exact fermentation and filtering process. Even the original maker (AbbVie) cannot produce two identical batches; they can only produce batches that are highly similar within a very tight, approved range. It is a complex mixture of related isoforms, not a single molecule.

4. Biosimilar (e.g., Amjevita):
This is a new winery (Amgen) that wants to replicate AbbVie’s famous wine. They are not given the secret recipe or the original yeast (the cell line). They must start from scratch.
They use advanced mass spectrometry to analyze the original Humira wine, identifying its key proteins, sugars, and acids. They reverse-engineer the process. They plant their own vines (develop their own cell line) and build their own fermentation vats (bioreactors) to create a wine that is analytically indistinguishable.
Then, they present their new wine to the FDA, the “Master Sommelier,” with a mountain of data (the “totality of the evidence”) to prove it:
“Look, our analytical chemistry shows our wine has the exact same protein structure.”
“Our lab tests show it has the same effect (PK/PD).”
“And our ‘taste test’ (a clinical trial) shows it produces the same clinical outcome and safety in patients.”
The FDA reviews this mountain of data and declares it “biosimilar”—not an identical copy (which is impossible), but a product with no clinically meaningful differences. Your job is to explain this process to providers—that this isn’t a “knock-off,” it’s a new master winery that has proven its product is just as good.

25.2.2 Deconstructing the Terminology: A Pharmacist’s Glossary

In this field, language is everything. Using the wrong term (“generic”) can destroy your credibility with a provider. You must master this glossary and use these terms with precision. They are the foundation of your authority on the subject.

Key Regulatory & Scientific Concepts

This is the clinical part of the proof. It’s the “taste test” that proves the wine has the same effect on the patient.
Term Official Definition HSSP “So What?” / Translation
Small-Molecule Drug A drug manufactured through chemical synthesis (e.g., atorvastatin, lisinopril). Low molecular weight, simple, stable, 100% characterized. The “caffeine” molecule. These get Generics via the ANDA pathway.
Biologic (Reference Product) A drug derived from a living system (e.g., yeast, bacteria, mammalian cells). High molecular weight, complex, heat-sensitive, often a mixture of isoforms. The “vintage of wine.” Approved via a full Biologics License Application (BLA), also called the “351(a) pathway.” This is Humira or Remicade.
Biosimilar A biologic product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. The “competing winery’s” product. Approved via the “abbreviated” 351(k) pathway. This is Amjevita (adalimumab-atto).
Interchangeable Biosimilar A biosimilar that has met additional FDA requirements, including “switching studies,” proving it can be substituted back and forth with the reference product without risk. The only kind of biosimilar that can be substituted at the pharmacy counter without provider intervention (like a generic), subject to state law. This is Semglee (insulin glargine-yfgn).
“Highly Similar” A scientific standard meaning that the structure (analytical characterization) of the biosimilar is compared to the reference product and any minor differences in inactive components are not clinically meaningful. This is the analytical part of the proof. It’s the “mass spec” data that proves the protein is the same. This is the base of the evidence pyramid.
“No Clinically Meaningful Differences” A clinical standard showing no differences in safety, purity, or potency. Proven with human PK/PD studies and, if needed, a comparative clinical trial.
Totality of the Evidence The FDA’s standard for approving a 351(k) biosimilar. It is a “pyramid” of data, with analytical studies as the foundation. This is your core argument to providers. The FDA didn’t just “do one small trial.” They approved this based on a totality of data, starting with foundational analytical proof.
Extrapolation of Indications FDA’s ability to approve a biosimilar for one or more of the reference product’s indications without a direct clinical trial for that indication. This is a huge source of provider confusion. “How can you say it works for Crohn’s if you only studied it in RA?” Your job is to explain the science.
Pharmacovigilance The practice of monitoring the safety of a drug *after* it has been released on the market. This is the entire reason for the next two terms. We need to be able to track which biologic a patient received if an adverse event occurs.
Non-proprietary Naming The “core name” (e.g., adalimumab) plus a unique, four-letter, meaningless suffix (e.g., -atto, -adbm, -bwwd). This is the “distinguishing” name. You must teach your EMR and staff to use the full name. Humira = adalimumab. Amjevita = adalimumab-atto. This is critical for billing and safety tracking.
The Purple Book The FDA’s “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” This is the “Orange Book” for biologics. It is your single source of truth for which products are biosimilar to, or interchangeable with, a reference product. You should have this bookmarked.

25.2.3 The Regulatory Pathway: 351(a) vs. 351(k) – A Deep Dive

As the team’s drug expert, you must be able to explain how these drugs are approved. The entire economic model of biosimilars rests on a more efficient, targeted, and data-driven regulatory pathway. Your community pharmacy experience taught you the ANDA (Abbreviated New Drug Application) for generics. This is the next level.

The Traditional Pathway: 351(a) Biologics License Application (BLA)

This is the pathway for a new, novel, reference product (e.g., Keytruda, Stelara). The manufacturer must prove safety and efficacy from scratch. The “evidence pyramid” is inverted, with massive clinical trials at its base.

  • Primary Goal: To prove the drug works for a specific disease.
  • Analytical Data: Used to set the “specs” for the drug and ensure manufacturing consistency.
  • Non-Clinical: Full toxicology and animal studies.
  • Clinical Data: This is the bulk of the $1-2 billion+ cost.
    • Phase 1: Safety and PK/PD in healthy volunteers.
    • Phase 2: Dose-finding and efficacy in a small patient group.
    • Phase 3: Two or more large, multinational, randomized, placebo-controlled trials to prove efficacy and safety in thousands of patients.

The result: The manufacturer must build a massive “pyramid” of evidence, with clinical efficacy trials as its enormous, expensive base.

The Abbreviated Pathway: 351(k) Biosimilar Application

This is the pathway for a biosimilar. The Bipartisan Budget and Accountability Act of 2009 created this pathway. Its goal is different. The goal is not to re-prove that adalimumab works for RA (we already know it does). The goal is to prove that your new product is adalimumab.

This flips the evidence pyramid on its head. The analytical data is now the massive, expensive base, and the clinical data is the smaller, confirmatory capstone.

The “Totality of the Evidence” Pyramid (Biosimilar 351(k) Pathway)
STEP 3: Clinical Studies (The Capstone)

Confirmatory PK/PD and immunogenicity studies. One comparative clinical trial in a sensitive population (if needed) to *confirm* no clinical differences. This is the smallest part of the dossier.

STEP 2: Non-Clinical Studies

In vivo animal studies to assess toxicity and pharmacology (only if analytical data is not sufficient).

STEP 1: Analytical Studies (The Foundation)

This is the bulk of the work. The manufacturer uses a huge battery of advanced tests (e.g., mass spectrometry, chromatography, functional assays) to prove that its molecule is “highly similar” to the reference product in its structure, purity, and biologic function. This is the most critical component.

The Science of “Extrapolation”: Your Most Important Talking Point

This is the concept providers struggle with most, and where you will provide the most value.
The Provider’s Objection: “The new infliximab biosimilar, Renflexis, was only studied in Rheumatoid Arthritis and Ankylosing Spondylitis. How can the FDA say it’s approved for my Crohn’s Disease patient? They never studied it in Crohn’s!”

HSSP Talking Points: Explaining Extrapolation

Your Response: “That’s an excellent question, Doctor. It’s one of the most confusing parts of the biosimilar pathway. The FDA’s approval for Crohn’s is based on a concept called extrapolation, and it’s built on a scientific bridge.

1. The ‘Bridge’ is the Mechanism of Action: We know that Remicade works in both RA and Crohn’s by blocking TNF-alpha.

2. The ‘Foundation’ is the Analytical Data: The manufacturer (Samsung) first proved to the FDA with a mountain of analytical data that their new molecule, Renflexis, is structurally and functionally identical to Remicade. It blocks TNF-alpha in the exact same way.

3. The ‘Confirmatory Step’ is the Clinical Trial: The FDA then required a clinical trial in a sensitive population—in this case, RA—to confirm that this analytical similarity translates to clinical safety and efficacy. They proved it has the same PK, efficacy, and immunogenicity as Remicade in RA patients.

4. The ‘Extrapolation’: Because the FDA is confident that (A) Renflexis is structurally Remicade, (B) it works the same way (by blocking TNF-alpha), and (C) it’s safe and effective in one sensitive population, they can scientifically ‘extrapolate’ that it will be safe and effective in other populations where the mechanism (TNF-alpha) is also the same. They don’t need to re-prove that blocking TNF-alpha works for Crohn’s; that was already proven 20 years ago.

So, the approval isn’t a guess—it’s a logical, scientific conclusion based on proving the molecule is the same. Our P&T committee has reviewed this complete dataset and feels confident making this our preferred infliximab.”

25.2.4 The Interchangeability Challenge: The HSSP’s Critical Role

If “biosimilar” is the most important new word, “interchangeable” is the most confusing. As an HSSP, you are the final authority on what this word practically means for your health system. The FDA’s legal definition and the operational reality in your hospital are two different things.

The FDA Definition: What “Interchangeable” Means

An interchangeable product is a biosimilar that has met a higher bar of evidence. To be designated “interchangeable” (the 351(k)(4) standard), the manufacturer must also prove that:

  1. The biosimilar is expected to produce the same clinical result as the reference product in any given patient.
  2. For a product administered more than once, the risk in terms of safety and efficacy of switching back and forth is not greater than using the reference product without switching.

The “Switching Study”: To prove #2, the manufacturer must conduct a “switching study.” This is a complex clinical trial where they take a group of patients, start them on the reference drug, then switch them to the biosimilar, then switch them back to the reference drug, and then back again to the biosimilar, all while monitoring for any loss of efficacy or, critically, any increase in immunogenicity (anti-drug antibodies).

The Legal Reward: If a manufacturer invests the time and money to get this “interchangeable” designation, their reward is that their product (subject to state pharmacy laws) can be automatically substituted by a pharmacist for the reference product, just like a generic, without the prescriber having to write a new prescription.

The HSSP Reality: Why P&T Approval Matters More

This is the critical insight. The “interchangeable” designation is a legal tool for community pharmacists who lack a P&T committee and collaborative practice agreements.

You, as an HSSP, operate within an integrated health system. Your “permission” to swap drugs doesn’t come from the FDA’s interchangeability designation; it comes from your P&T Committee.

When your P&T committee reviews the data for a non-interchangeable biosimilar (e.g., Amjevita) and votes to make it the “preferred adalimumab,” they are simultaneously authorizing a therapeutic interchange protocol. This protocol gives you permission to switch patients from Humira to Amjevita, even though it’s not “interchangeable.”

Interchangeability vs. Therapeutic Interchange: Do Not Confuse Them

You must be able to explain this to your pharmacy technicians, buyers, and providers.

Pharmacist-Level Substitution (Interchangeable):
Who: Any pharmacist (community, mail order, etc.).
What: Swapping Lantus (reference) for Semglee (interchangeable) at the point of dispensing.
Permission: Granted by FDA designation + state pharmacy law.

System-Level Therapeutic Interchange (HSSP):
Who: An HSSP pharmacist or technician working under a pharmacist.
What: Swapping Humira (reference) for Amjevita (a non-interchangeable biosimilar) for all patients in the health system.
Permission: Granted by your internal P&T Committee, which has approved this specific swap as clinically and financially appropriate for your organization.

Key Takeaway: For an HSSP, the “interchangeable” designation is nice to have and builds confidence, but it is not required for you to build and execute a successful, system-wide biosimilar conversion strategy. Your P&T protocol is your power.

25.2.5 Market Dynamics and Pricing Pressures: The “Patent Thicket” and the “Rebate Wall”

If the science is sound, why has the US market been so slow to adopt biosimilars compared to Europe? The answer is not clinical; it is purely financial and legal. As an HSSP, you are on the front lines of this battle, and you must understand the two great “boogeymen” of the biosimilar market.

1. The “Patent Thicket”

This is why biosimilars are delayed for years.
Small-Molecule Generic: A drug like Lipitor is protected by one or two key patents (the molecule, the method of use). When that date (the “patent cliff”) arrives, a flood of generics can launch.
Biologic: A reference biologic is not protected by one patent. It is protected by a “thicket” of hundreds of patents. AbbVie, for example, had over 250 patents on Humira. These patents cover:

  • The primary molecule sequence (this is the original, oldest patent).
  • The manufacturing process (e.g., “a method of culturing CHO cells at 36.5°C”).
  • The formulation (e.g., “a citrate-free buffer with polysorbate 80”). This was the “sting-free” Humira patent.
  • The delivery device (the “Humira pen”).
  • The indication (a separate patent for using it in Crohn’s, another for PsO, etc.).

The HSSP “So What?”: A biosimilar manufacturer (e.g., Amgen) can’t just launch when the main patent expires. They must fight or settle all of these “thicket” patents. This is why Amjevita (adalimumab-adbm) was FDA-approved in 2016 but, due to a patent settlement with AbbVie, could not launch in the US until January 31, 2023. This entire market is dictated by patent attorneys, and your job is to explain this dynamic to your C-suite when they ask, “Why can’t we get this cheaper drug that’s approved in Europe?”

2. The “Rebate Wall”

This is why, even after biosimilars launch, they struggle to gain market share. This is the single most important, and perverse, financial incentive in the US drug market, and you must be able to explain it to a 5-year-old.

The PBM (as we learned in 25.1) negotiates a rebate from the manufacturer for preferred formulary status. The PBM’s profit is often a percentage of this rebate. This creates the “Rebate Wall.”

Understanding the “Rebate Wall”: A Case Study

You are a PBM. You have two drugs to choose from for your “Preferred” formulary slot. Your profit is 10% of the rebate you collect.

OPTION 1: Humira (Reference)
  • List Price (WAC): $6,000 / month
  • Rebate Offered: 50% ($3,000)
  • Net Price to Payer: $3,000
  • PBM Profit (10% of Rebate): $300
OPTION 2: Amjevita (Biosimilar)
  • List Price (WAC): $3,000 / month
  • Rebate Offered: 10% ($300)
  • Net Price to Payer: $2,700
  • PBM Profit (10% of Rebate): $30
The Perverse Incentive:

As the PBM, which drug do you “prefer”?
Amjevita is $300 cheaper for your client (the health plan/employer).
Humira makes YOU 10x more profit ($300 vs. $30).

The PBM will “prefer” Humira, the higher-cost drug, because it is more profitable for them. They will block the cheaper biosimilar by placing it on a “non-preferred” or “excluded” tier. This is the “Rebate Wall,” and it is the single biggest barrier to biosimilar adoption in the US.

The HSSP Advantage: Your HSSP is one of the few places that can break this wall. Because you are part of an IDN, your health system may “carve out” the specialty benefit from the PBM. This means your P&T committee, not the PBM, makes the formulary decision. You can look at the two “net prices” ($3,000 vs. $2,700) and choose the truly cheaper drug, Amjevita, saving the system $300 per fill. This ability to “ignore the rebate wall” and purchase based on true net cost is a primary value proposition of an HSSP.

25.2.6 The HSSP as Formulary Strategist: Building the Biosimilar Playbook

This is your “how-to” guide. A biosimilar has been FDA-approved, the patents have been settled, and it’s launching. The manufacturer’s rep is in your office, and your P&T committee has tabled it for the next meeting. What do you do? You are now the project manager for a “Biosimilar Formulary Assessment.”

Phase 1: The Three-Pillar Assessment

You must present a comprehensive review to P&T. Your monograph must go beyond the package insert and analyze three key domains.

Assessment Pillar Key Questions You Must Answer Who You Work With
1. Clinical Assessment
  • What does the “totality of the evidence” look like? How robust is the analytical data?
  • Was there a clinical trial? In what population?
  • Is it “interchangeable”? If not, why? Were there switching studies?
  • Did they seek extrapolation for all indications? If not, why?
  • Are there any differences? (e.g., formulation, buffer, delivery device, injection volume, storage requirements).
 P&T Committee, Key Opinion Leaders (e.g., Chief of Rheumatology).
2. Financial Assessment
  • What is the WAC? What is our GPO price?
  • What is the 340B price? (Often the same as the reference drug, neutralizing the benefit).
  • What is our payer mix for this drug?
  • For our “carved-in” (PBM-managed) patients, what is the PBM’s preferred agent?
  • For our “carved-out” (self-funded) plan, what is the true net price after all rebates?
  • What patient assistance programs is the new manufacturer offering? Are they as good as the reference drug’s?
 Finance Dept, 340B Coordinator, Supply Chain, Managed Care.
3. Operational Assessment
  • How many NDCs does this add to our system?
  • Can our EMR (Epic, Cerner) handle it? How will it appear in order sets?
  • Can our inventory system (e.g., Pyxis) store it? Does it have different storage (e.g., room temp stability) than the reference?
  • Does the new device require a massive re-education campaign for 5,000 patients and 500 nurses?
  • Do our billing and prior auth teams know how to bill for the new J-code / Q-code / NDCs?
 IT/EHR Team, Pharmacy Informatics, Nursing Education, Revenue Cycle.

Phase 2: The Formulary Decision & Strategy

After your assessment, you will recommend a strategy to P&T. There is no one right answer. It depends on your system’s tolerance for disruption vs. its need for savings.

Strategy What It Is Pros Cons
Reference-Only P&T reviews the biosimilar and votes “no,” or to add it as “non-preferred.” The reference drug remains the only agent on the formulary. Zero disruption. No provider/patient education needed. No EMR build. Zero savings. You are leaving millions of dollars on the table. (This is a failing strategy).
“Biosimilar Preferred, New Starts Only” The P&T makes the biosimilar the preferred agent. All new Rxs must be for the biosimilar. Existing, stable patients are “grandfathered” on the reference drug. Moderate savings, low disruption. Providers are happy (stable patients are untouched). Allows a “slow roll” adoption. Slow savings ramp-up. Operationally complex (you now must stock two drugs). Creates “haves” and “have-nots” among patients.
“Forced Switch” / Hard Conversion The P&T votes to remove the reference drug from the formulary entirely. All 5,000 patients on Humira *must* be switched to Amjevita by a set date. Massive, immediate savings. Operationally simpler (you only stock one drug long-term). Maximum disruption. Huge, high-touch project for your HSSP team. High risk of provider/patient dissatisfaction and nocebo effect.
“Payer-Driven” / Multi-Winner You *add* the biosimilar to the formulary. Your EMR now contains the reference + 3 biosimilars. The “preferred” drug is whatever the patient’s PBM dictates. Keeps PBMs happy. Ensures lowest patient OOP (if they are on the PBM’s preferred agent). Operational catastrophe. Your inventory is bloated. Your EMR is a mess. Your team must do a “mini-PA” on every fill to see which drug is covered.

25.2.7 Provider and Patient Acceptance: The “Soft Skills” of the Switch

This is where the entire strategy lives or dies. You can have the best financial model in the world, but if the providers don’t prescribe it and the patients don’t take it, you have failed. This “change management” is a core HSSP competency.

Overcoming Provider Hesitancy

Providers are scientists, but they are also creatures of habit. Their primary concern is “My patient is stable, why rock the boat?” You must counter this inertia with data, confidence, and partnership.

HSSP Playbook: Provider Academic Detailing

Do not rely on emails. You must go to their clinics, to their grand rounds, and to their department meetings. This is “academic detailing.”

Your 3-Point “Elevator Pitch” for Providers:

  1. “The Science is Solid.” (This is where you use your “extrapolation” script). “Dr. Smith, our P&T committee, including Dr. Jones from your own department, did a deep dive on the FDA’s ‘totality of the evidence’ for Amjevita. The analytical and clinical data are robust. The FDA has confirmed no clinically meaningful differences. We are confident this is a safe and effective switch.”
  2. “The ‘Why’ is Our Health System.” “This isn’t just a PBM game. This is our health system’s stewardship plan. The $10 million in savings we project from this one switch is being used to fund [the new infusion center, two new NPs for your clinic, etc.]. This is how we keep our system financially healthy.”
  3. “We Are Doing 100% of the Work.” “This is the most important part. You don’t have to do anything. My pharmacy team has already built the EMR alerts. We will identify all 500 of your patients on Humira. We will send you a single, pre-signed protocol order to approve the switch. We will call every single patient, conduct a 1-on-1 education session, perform the new device training, and manage the benefits investigation. Your clinic will not get a single phone call. We are your partners in this.”

Overcoming Patient Hesitancy & The “Nocebo Effect”

The “nocebo effect” is your primary clinical enemy in a biosimilar switch. It is a real, documented phenomenon where a patient, believing a new drug is inferior, will develop real, negative side effects (e.g., pain, fatigue, rash) that are caused by the anxiety of the switch, not the drug itself. Your communication strategy is the only “antidote.”

The HSSP’s “Nocebo Antidote” Patient Script

This script is built on transparency, positive framing, and empowerment.

HSSP: “Hi [Patient Name], this is [Your Name], one of the specialty pharmacists at [Health System]. I have some great news about your Humira therapy. Your care team, including Dr. Smith, is moving all of our patients to a new, FDA-approved version of your medication called Amjevita.”

Patient: “A new version? What does that mean? Is it a cheap generic?”

HSSP: “That is the most common question we get! It’s not a generic. It’s what the FDA calls a ‘biosimilar.’ This means it’s still a complex biologic, made from a living system, just like Humira. To get approved, the manufacturer had to prove to the FDA with a mountain of data that it is just as safe and just as effective as Humira. Dr. Smith and our P&T committee have reviewed all that data and are very confident in it.”

Patient: “So… why switch? If it’s the same, why change?”

HSSP: “The main reason is for our health system. By using Amjevita, our hospital is able to save significant resources, which helps us invest in other patient care areas and keep costs down for everyone. What’s most important for you is that the drug itself will work the exact same way. In fact, many patients prefer the Amjevita pen because it’s a ‘push-button’ autoinjector, which can be more comfortable.”

Patient: “Oh, the pen is different? I’m nervous about that.”

HSSP: “That’s the main change you’ll notice, and I’m here to make it easy. I have a trainer pen I can mail to you, and we can do a video call to practice together. My direct number will be on the box. You can call me any time, day or night, if you have a question. Your doctor is fully aware, and our whole pharmacy team is here to support you through this. How does that sound?”

Key Principles of this Script:
1. Positive Framing: “Great news” (not “We have to switch your drug”).
2. Define & Reassure: “Biosimilar,” “just as safe and effective.”
3. Name the “Why”: Be transparent. “It saves our system money.”
4. Acknowledge the Difference: “The pen is different.” Don’t hide it.
5. Provide Solutions & Support: “Trainer pen,” “video call,” “my direct number.” You are their high-touch safety net.

25.2.8 The Future: “Bio-Betters” and the Evolving HSSP Role

The market doesn’t stand still. Just as biosimilars are launching to compete with 10-year-old biologics, reference manufacturers are already launching the next generation of their drugs to make the old ones obsolete. This is the “bio-better.”

“Bio-Betters” vs. Biosimilars

A bio-better is a biologic that is intentionally different from the reference product to improve it. This is a manufacturer’s life-cycle management strategy.

Case Study: Neupogen (filgrastim) vs. Neulasta (pegfilgrastim)

  • Neupogen (filgrastim): The original G-CSF. Had to be injected daily for 7-10 days.
  • Biosimilars (e.g., Zarxio): Launched as biosimilars to Neupogen. Also have to be injected daily.
  • Neulasta (pegfilgrastim): The “bio-better.” The manufacturer (Amgen) took its own filgrastim molecule and attached a polyethylene glycol (PEG) chain. This pegylation dramatically increased the half-life, allowing for a single injection per chemo cycle instead of 7-10.

The “So What?”: Neulasta is a new drug (a new 351(a) BLA), not a biosimilar. It gets its own 20 years of patent protection. This effectively killed the market for Neupogen long before its biosimilars arrived. Manufacturers are doing this for all their blockbusters. They are working on subcutaneous versions of IV drugs (e.g., Remicade SC), longer-acting formulations, or combination products.

Your HSSP Role: You must now assess three things at P&T:
1. The original reference drug.
2. The new biosimilars for that drug.
3. The new “bio-better” for that drug.

You are the one who has to do the complex value analysis: “Is the ‘bio-better’ (e.g., one shot) worth a 30% price premium over the ‘biosimilar’ (e.g., 10 shots), even if the clinical outcome is the same?” This moves you from a simple cost analysis to a complex “total cost of care” and “patient preference” analysis.

Conclusion: The evolution of the biologic market is the single greatest practice-changer for the HSSP. It elevates your role from a clinical dispenser to an enterprise portfolio manager. You are responsible for managing a multi-hundred-million-dollar portfolio of complex drugs. Your expertise in the science (totality of the evidence), the financials (the rebate wall), and the “soft skills” (the nocebo effect) is what makes you the indispensable leader of this entire, ongoing transition.