In this episode, TRC Healthcare editor, Vickie Danaher, PharmD, guides listeners through the evolving landscape of biosimilars, highlighting their increasing presence in pharmacy practice and their critical distinctions from traditional generics. She explains the science behind biologics, the FDA’s rigorous approval process for biosimilars, and the nuances of interchangeability. With examples of biosimilars for Stelara, Humira, and Prolia, Vickie illustrates how pharmacists can confidently counsel patients, verify product details, and stay compliant with state laws.
Whether you’re stocking shelves or answering patient questions, this episode equips you with the knowledge to handle biosimilars with confidence, precision, and care.
This is an excerpt from our January 2025 Pharmacy Essential Updates continuing education webinar series.
The clinical resources mentioned during the podcast are part of a subscription to Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights:
- Article: Brush Up on Biosimilars
- FAQ: Facts About Biosimilars
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Transcript:
This transcript is automatically generated.
0:00:03 Narrator
Welcome to Clinical Capsules, your go-to podcast and trusted source for quick, evidence-based insights from TRC Healthcare.
0:00:11 Narrator
For four decades, we’ve been keeping healthcare professionals at the forefront of drug information and medical knowledge, and now we’re bringing these vital clinical updates right to your ears with new episodes every 2nd and 4th Tuesday – delivering practical, actionable takeaways in bite-sized episodes.
0:00:28 Narrator
Today, Associate Editor and Clinical Pharmacist Vickie Danaher breaks down the complex world of biosimilars, their role in practice, and how to help ensure appropriate use, in an excerpt from our popular Pharmacy Essential Updates webinar series. Let’s take a closer look…
00:00:50 Vickie Danaher
We know that over the years more and more biosimilars have been approved with the goal of trying to increase access and lower cost of meds for more complex or advanced diseases.
00:01:01 Vickie Danaher
And like our article says, you’ll see even more prescriptions for biosimilars now that there are over 60 available in the United States.
00:01:10 Vickie Danaher
And over 16 of these were approved in 2024 alone.
00:01:15 Vickie Danaher
So to kind of Orient everyone here, some of the more common biosimilars that we may be familiar with or that have been around for a while are ones such as Semglee (insulin glargine –yfgn), which is a biosimilar to Lantus.
00:01:30 Vickie Danaher
Or Inflectra (Infliximab-dyyb), which is a biosimilar for Remicade.
00:01:37 Vickie Danaher
And now we have a multitude of new biosimilars that we’ll need to be aware of. For example, in 2024, FDA approved six different biosimilars to Stelara or USTEKINUMAB, which is often used for plaque psoriasis, Crohn’s disease or ulcerative colitis.
00:01:57 Vickie Danaher
Another example is Jubbonti or denosumab-bbdz, which was approved as the first interchangeable biosimilar to Prolia or denosumab, which we sometimes see patients get for osteoporosis.
00:02:14 Vickie Danaher
So we’ll need to be ready to talk to patients and prescribers about these products and biosimilars in general and how they compare and then know how to dispense them properly.
00:02:26 Vickie Danaher
But when we’re talking about biosimilars, there’s a lot of terminology gets thrown around and it can be kind of confusing to understand because there’s biologics, biosimilars, reference biologics and interchangeable biosimilars.
00:02:42 Vickie Danaher
So before we go any further, let’s get on the same page about what all of these terms mean, and then how these products compare to most traditional meds that we’re used to dispensing.
00:02:53 Vickie Danaher
And to help us understand what biosimilars are, we first have to understand biological products, which we typically just refer to as biologics.
00:03:04 Vickie Danaher
So biologics are products that usually contain large and complex molecules and that are made in a living system such as a plant or animal cell using biotechnology methods.
00:03:17 Vickie Danaher
And this is different than most traditional drugs like aspirin or atorvastatin, for example, that have a small, simple and well defined structure, and that are made by a chemical process.
00:03:32 Vickie Danaher
There are many different types of biologics approved by FDA, including monoclonal antibodies such as adalimumab or therapeutic proteins such as filgrastim.
00:03:45 Vickie Danaher
But because biologics come from living organisms, and their structures are much more complex than other medications, biologics are often more complicated to purify, process and manufacture.
00:03:58 Vickie Danaher
And their structure cannot be copied exactly.
00:04:02 Vickie Danaher
So rather, manufacturers can only produce a similar version of the biologic.
00:04:08 Vickie Danaher
And that’s where the term biosimilar comes in.
00:04:12 Vickie Danaher
So biosimilars are biological products that have been shown to be highly similar to an already approved biologic known as the reference product or biologic?
00:04:25 Vickie Danaher
And biosimilars must show no clinically meaningful differences from the original reference product in safety, purity and potency.
00:04:36 Vickie Danaher
A biosimilar products can only be approved if it has the same dosage form, route of administration, strength, and mechanism as the reference biologic.
00:04:46 Vickie Danaher
But minor differences such as clinically inactive components are allowed. So there could be a slight difference. For example, in a stabilizer or in a buffer compared to what’s in the reference product.
00:05:00 Vickie Danaher
And although biosimilars may be approved for all of the same uses as the reference product, biosimilars may have fewer indications.
00:05:09 Vickie Danaher
This is mostly due to patent protection, not a lack of effectiveness.
00:05:16 Vickie Danaher
Biosimilars must also be rigorously tested by the manufacturers following the same robust quality assessments as their reference products to meet FDA’s high standards for approval.
00:05:30 Vickie Danaher
So if we talk through this as an example, I think this will help us see where all of this fits in.
00:05:35 Vickie Danaher
So, let’s hone in on Stelara, so Stelara or ustekinumabwould be considered the original reference biologic.
00:05:45Vickie Danaher
And some approved biosimilars for Stelara include Selarsdi or ustekinumab-aekn or Otulfi (ustekinumab-aauz).
00:06:04 Vickie Danaher
So these products are highly similar to Solara and have no clinically meaningful differences in safety, purity and potency.
00:06:14 Vickie Danaher
So we can reassure patients prescribed A biologic such as Stelara that it’s OK to start or switch to a biosimilar and that biosimilars are just as safe as effective as the original reference product that they’re compared to.
00:06:29 Vickie Danaher
But be aware that biosimilars aren’t generics.
00:06:33 Vickie Danaher
Even though biosimilars and generics are both versions of brand name drugs, there are some important differences.
00:06:43 Vickie Danaher
For example, we know that with generic meds, the active ingredient is exactly the same as in the brand name drug.
00:06:51 Vickie Danaher
But with biosimilars, again, it’s not possible to create an exact copy of that original reference biologic, since biologics contain larger, more complex molecules than traditional drugs.
00:07:05 Vickie Danaher
Biosimilars and generics are each approved through different pathways and they have different rules regarding substitution.
00:07:15 Vickie Danaher
A biosimilar can usually only be automatically substituted for the reference biologic if that biosimilar is also approved by FDA as being interchangeable. And if your state allows.
00:07:31 Vickie Danaher
And being interchangeable means that the product meets additional FDA requirements for switching.
00:07:38 Vickie Danaher
Such as being able to show a similar clinical result as the original reference biologic.
00:07:45 Vickie Danaher
So for a quick example here Semgle is interchangeable with Lantus, since Semgle shows similar A1C lowering.
00:07:55 Vickie Danaher
On top of that, an interchangeable biosimilar also generally has to show no decrease in effectiveness or increase in risk when switching to or from the reference biologic.
00:08:08 Vickie Danaher
Now it’s important to be aware that manufacturers decide whether to apply their product for this interchangeable status, and if a biosimilar is approved as interchangeable, this doesn’t necessarily mean that it’s safer or more effective than other biosimilars. It just means that its regulatory status allows it to be automatically substituted for the reference biologic.
00:08:32 Vickie Danaher
And to find out if a biosimilar is interchangeable, you can use FDA’s Purple Book online, which you can access by going to purplebooksearch.fda.gov.
00:08:45 Vickie Danaher
And basically you just enter the biologics name and then a list of biosimilars and interchangeable biosimilars will pop up along with additional information such as the product labeling for each product.
00:09:00 Vickie Danaher
So if we search the Purple book for Humira.
00:09:03 Vickie Danaher
It shows that some interchangeable biosimilars to Humira are Abrilada, Amjevita, Cyltezo. and then others. So again, this means that these products can automatically be substituted for Humira again if your state allows.
00:09:22 Vickie Danaher
On the other hand, biosimilars that are not approved as also being interchangeable cannot automatically be substituted, and if a pair requires using one of these products, you’ll usually need to contact the prescriber for a switch.
00:09:39 Vickie Danaher
Ultimately, we should prepare preparers to drive the choice of which product a patient will get, so continue to watch for pair messaging to see if a particular Med is covered.
00:09:50 Vickie Danaher
Biosimilars are often preferred by payers as they’re less costly, but they can still be expensive.
00:09:57 Vickie Danaher
For example, the biologic tocilizumab or ACTEMRA for rheumatoid arthritis costs about $1200 for a dose.
00:10:07 Vickie Danaher
But its biosimilar tocilizumab-aazg costs about $760.00, so it’s about $400.00 less expensive per dose.
00:10:22 Vickie Danaher
We also want to make sure that you know and follow any other laws that your state may have about substitution.
00:10:28 Vickie Danaher
Many states require pharmacies to inform the patient or prescriber, even when substituting an interchangeable biosimilar.
00:10:36 Vickie Danaher
And a handful of seeds require contacting the prescriber before substitution.
00:10:44 Vickie Danaher
When patients are getting a biosimilar help prevent mix UPS by verifying key details in the product’s name.
00:10:51 Vickie Danaher
So FDA’s naming convention for biosimilars is a core name which is the non-preparatory name of the reference product followed by an FDA designated suffix composed of four lower case letters and a hyphen.
00:11:08 Vickie Danaher
So here the core name is ustekinumab and the FDA designated suffix is AUUB.
00:11:16 Vickie Danaher
Now, most of these suffixes don’t really make any sense, and they’re kind of made-up so they aren’t easy to remember.
00:11:22 Vickie Danaher
For example, if we look at the names of the Stelara biosimilars, Yesintek is ustekinumab-kfce. And Imuldosa is ustekinumab-slrf. So I think it’s obvious here how all these can be so easy to confuse and keep straight.
00:11:43 Vickie Danaher
So when dispensing these products or adding them to Med list, we need to make sure to choose the specific biosimilar that patients are using and we want to verify the trade name and that four letter suffix, especially if you stock multiple biosimilars.
00:12:01 Vickie Danaher
We also want to check for possible differences among products, so things like storage requirements, shelf life, available doses, or even the presence of inactive ingredients such as latex or citrate could vary between biosimilars or between biosimilars and the reference product.
00:12:19 Vickie Danaher
So it’s a good idea to review package labeling closely, especially when there’s a switch.
00:12:27 Vickie Danaher
I know this is a big topic to digest and it also took me a few times to wrap my head around it, so fortunately we have this nice resource online called facts about biosimilars that you can use to brush up on this topic and help work through any questions that come up in your practice.
00:12:44 Narrator
We hope you enjoyed and gained practical insights from listening to this presentation!
00:12:49 Narrator
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00:13:06 Narrator
Also in the show notes, we’ve linked directly to a few of the excellent resources mentioned today available to subscribers of Pharmacist’s Letter, Pharmacy Technician’s Letter, or Prescriber Insights. On those websites you’ll also find a lot more evidence-based, concise, yet comprehensive resources on this and other medication therapy topics.
00:13:25 Narrator
And don’t forget to check out our full Pharmacy Essential Updates webinar series for deeper dives into topics that matter to your practice.
00:13:34Narrator
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00:13:47 Narrator
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00:14:10 Narrator
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00:14:14 Narrator
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00:14:22 Narrator
Thanks for listening, stay sharp, stay current, and we’ll catch you next time on Clinical Capsules!
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