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WHEN CHOICE ARRIVES: Competition & Consequences

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The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.

FDA Approves High-Concentration Cyltezo

April brought 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Biosimilars Policy Roundup: April 2024

During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.

Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability

The approval marks the sixth for a biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast and gastric cancers.

FDA Approves Henlius’ Trastuzumab Biosimilar, Hercessi

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Clinical

The Evolving Treatment Landscape of Acid-Related Disorders: The Role of New and Emerging Potassium-Competitive Acid Blocker Therapies (Pharmacist Credit)

Patent thickets, patent litigation, patent dances—all of these legal terms have plagued the biosimilar space, causing many biosimilar products to launch well after the originator's market exclusivity was supposed to expire. A perfect example of this is the Stelara (ustekinumab) space, where patent litigation settlements have led to delayed market access for ustekinumab biosimilars from late 2023 to early 2025. Additionally, congressional leaders have had to investigate AbbVie for potentially abusing the patent system to stall biosimilar competition for Humira (adalimumab).

But why does the system work like this? What can be done to improve it? What actions can be taken to ensure the patent system doesn't hinder competition and innovation?

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

To read more of Ha Kung's thoughts on the US patent system and its role in the biosimilar landscape, 

To learn more about Congress' role in addressing AbbVie's alleged anticompetitive practices regarding adalimumab products, 

To learn more about the suit filed by CareFirst BlueCross BlueShield regarding ustekinumab biosimilar delays, 

To learn more about the settlements that have resulted in the market delay of ustekinumab biosimilars, 

To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, 

To learn more about what types of patents are at most to blame for biosimilar market delays, 

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports  quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

Happy Birthday Adalimumab Biosimilars: Reflecting on the First Year of US Competition

EMA Approves First Ustekinumab Biosimilar, Uzpruvo

Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars

IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe

IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition

Report: Varied Biosimilar Uptake Speeds Pose Missed Opportunities for Cost Savings

Biosimilar SB5 Matches Originator in Safety, Efficacy for Inflammatory Diseases After Switching

Postapproval Pharmacovigilance Review Confirms Comparable Safety Between Sandoz Biosimilars, Originators

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition

As 2023 comes to a close, we look back on some of the major advancements from the past year, from the long-awaited market introduction of adalimumab biosimilars in the US, to the first major regulatory approvals for neurology biosimilars, to the implementation of key policy initiatives around the globe.

A lot of eyes have been on the United States and 2024 shapes up to be another big year for the biosimilar industry, with approvals for denosumab, aflibercept, and on-body pegfilgrastim biosimilars on the way. Additionally, the nation will continue to see the fallout from the implementation of the Inflation Reduction Act (IRA), including its policies regarding Medicare price negotiations, as well as the role interchangeability designations will play into adoption rates. It also remains to be seen whether payers and pharmacy benefit managers (PBMs) are ready to embrace newer biosimilars and add them to formularies as preferred products, leaving the future for a sustainable biosimilar industry up in the air.

Today, I'm joined by Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and patient access, and policy insights at Cencora (formerly AmerisourceBergen). Both of them have been keeping a close watch on the biosimilar space throughout the year and today's discussion will surround how this year sets up a new chapter for the industry.

To learn more about the prospect for Neulasta OnPro biosimilars, 

To learn more about how the IRA will impact biosimilars, 

To learn more about the dual-pricing strategy being used for adalimumab biosimilars, 

To hear Brian's insight into how the ophthalmology biosimilar industry is developing, 

To listen to previous Not So Different episodes featuring more of Brian's insight into how the adalimumab market will develop and biosimilar pricing trends, 

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond

In late October 2023, the FDA approved Zymfentra (infliximab-dyyb), the world's first subcutaneous infliximab product. The product's development was based on Inflectra (infliximab-dyyb), an intravenous infliximab biosimilar referencing Remicade (infliximab). However, because the reference product does not have a subcutaneous option, Zymfentra was approved as a novel agent.

Zymfentra is also approved in Europe, where it's marketing under a different brand name. The product was developed by Celltrion, a Korean biopharmaceutical manufacturer that's shaping up to be a big player in the US biologics space. Zymfentra's subcutaneous presentation allows for easier and more convenient self-administration for patients, particularly those with inflammatory bowel disease (IBD), an umbrella term for ulcerative colitis and Crohn disease.

Zymfentra is also unique in that it was approved using data from 2 trials testing the product vs placebo in patients with ulcerative colitis and Crohn disease. Typically, infliximab biosimilars are tested in patients with RA or PsA and receive extrapolated indication for gastroenterology conditions. The LIBERTY trials offer gastroenterologists who may be wary of a subcutaneous infliximab option a degree of confidence that Zymfentra is safe and effective for patients currently on intravenous infliximab treatments.

We spoke with Andres Yarur, MD, a researcher on the LIBERTY trial and an associate professor of medicine at Cedars-Sinai Medical Center, to discuss the significance of his trial, the approval of a subcutaneous infliximab option, and what both mean for the future of IBD care.

To learn more about the FDA approval of Zymfentra, 

To learn more about the results from the LIBERTY trials, 

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur

When it comes to the US biosimilar industry as a whole, adalimumab is on everyone's mind. 2023 ushered in a new age for these products and so far, 8 adalimumab biosimilars have entered the market and companies are looking for any way to stand out from the crowd. Some have chosen to use a dual pricing strategy to both get on formulary and offer steep discounts, some have chosen to align their prices more with the reference product (Humira), some are leaning on their interchangeability or high-concentration labeling in hopes of becoming the new preferred adalimumab option among pharmacy benefit managers and providers. However, whether these new biosimilars, if any of them, will gain significant market share or generate meaningful savings for Americans will remain to be seen.

Today, we're joined by Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, to discuss the initial market reaction to adalimumab biosimilars and her predictions for how the rest of the year will play out. Gregory recently published a paper claiming that adalimumab biosimilars will transform the US health care industry and she's been keeping a keen eye on how this is playing out in the real-world setting. She's also well-versed on the European and Canadian experiences with these products and can provide valued insight into how the United States' health system can champion the use of these products.

To read more about Dr. Gregory's commentary piece, 

To read more about Cardinal Health's 2023 Biosimilars Report, 

To learn more about adalimumab biosimilars, 

To learn more about the adalimumab biosimilars that have launched so far in the US:

 for the launches of Hyrimoz, Hadlima, Yusimry, and Cyltezo

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.


Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?

July 2023—the moment the entire US biosimilar industry has been waiting for. This month 8 adalimumab biosimilars will launch on the market, and as of this recording, 7 have made their market debut. This represents the most biosimilars to launch in a single month and adalimumab is officially the drug class with the highest number of biosimilar options. These drugs all reference Humira, one of the most profitable drugs in the world, largely because it has 11 indications across the rheumatology, dermatology, immunology, and gastroenterology (GI) spaces.

In particular, adalimumab biosimilars open the doors for massive savings for patients with inflammatory bowel disease (IBD), an umbrella term for Crohn disease and ulcerative colitis. However, like other treatment spaces, the GI space must overcome misconceptions and misinformation regarding the safety and efficacy of IBD biosimilars, highlighting the need for more education resources for patients and providers alike.

Today, I'm joined by Laura Wingate, executive vice president, education, support and advocacy at the Crohn's & Colitis Foundation. She has been working with the foundation for over 16 years and has seen the market transform before her eyes as more gastrointestinal biosimilars enter the market. She is passionate about expanding access to IBD treatments and raising awareness about the emergence of IBD biosimilars, as well as their benefits and savings potentials.

To learn more about the adalimumab products that have launched in the US so far, click 

Laura Wingate, from the Crohn's & Colitis Foundation, explains some of the challenges regarding educating patients and providers on biosimilars for inflammatory bowel disease (IBD) as well as whether the gastroenterology space is ready for the influx of adalimumab biosimilars.

Adalimumab Biosimilars Take Center Stage: A Game Changer for IBD Treatment

In 2023, between 7 and 10 adalimumab biosimilars referencing blockbuster drug Humira will finally enter the US market. This is most biosimilars the United States has ever had for the same reference product, and they’re all coming out in a short amount of time, meaning that everyone is wondering exactly how this is going to play out. 

This summer, Vizient, a member-owned health care consulting company, published its Pharmacy Market Outlook report for 2022. The report provided insight into the current status of the US biosimilar market place and broke down some of the key aspects stakeholders should keep an eye on as the United States enters a new phase of biosimilar competition.

 welcomes Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient. Prior to his work with Vizient, Dr. Lucio practiced for almost 10 years within the Baylor Health Care System in various settings, including ICU clinical pharmacy and geriatric ambulatory care. Dr. Lucio has been working with Vizient on its Pharmacy Market Outlook report, which makes several predictions for how the biosimilar market is expected to develop in the near future, including how the first year of adalimumab biosimilars in the United States may play out.

This special episode is part of a larger series called “WHEN CHOICES ARRIVE: Competition & Consequences,” consisting of 4 articles and 2 podcasts. The series delves into everything that stakeholders need to know as everyone prepares for the 2023 introduction of adalimumab biosimilars.

 of the series are available now. Readers can expect podcast 2 on September 25 and part 4 on September 27.

To read part 1 of this series, “Biosimilars to Bring a Bumper Crop of Adalimumab Options,” click 

To read part 2 of this series, "Part 2: For Patients and Employers, 2023 Means a Changed Landscape," click 

To read more about Vizient’s Pharmacy Market Outlook report, click 

To read more about Vizient’s provider survey, click 

As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to maintain a robust market.

What Will Year 1 Look Like for Adalimumab Biosimilars?

With new research being presented, and with new biosimilars in the pipeline that target inflammatory bowel disease, October was a notable month for biosimilars in the gastroenterology space. This week on the podcast, we’re rounding up the top developments in gastroenterology for the month of October 2019. 

To read more about the topics discussed in this podcast, 

"Not So Different": What's New in Biosimilars in Gastroenterology

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.

Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar

A review article summarized the totality of evidence supporting the approval of the adalimumab biosimilar GP2017 (Hyrimoz; Sandoz) in the United States and Europe.

The Totality of Evidence Supporting the Approval of Adalimumab Biosimilar GP2017

In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.

Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch

Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

Julie Reed: Why 2024 Is Important for Biosimilars

Chelsee Jensen, PharmD, explains adalimumab pricing strategies

Dr Chelsee Jensen Discusses Pricing Strategies for Adalimumab Biosimilars

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the interchangeability approval for Abrilada and attempts to explain the purpose of dual-pricing strategies for adalimumab biosimilars.

Several adalimumab products that entered the US market this year launched with 

. Can you explain why a company would use this pricing strategy and do you think this trend will continue in other markets?

I do think with the pharmacy benefit drugs, we might continue to see this trend. And this is happening because, again, from a manufacturer standpoint, in order to get on to some of these insurance formularies, we realize that some insurance companies have a historical precedence of being used to these large back end rebates. So that's, we'll see manufacturers potentially come into the market with 2 list prices to be more appealing to those insurer markets, whether they want the lower discount or the more deeper discount. 

But one thing that we'll have to kind of keep trending and watching out for in this space, especially with adalimumab, is what's happening to the patient. I know a lot of talk or assumption is that the patient will utilize manufacturer co-pay assistance. However, we have to recognize that not every single patient on an insurance plan is going to qualify for that. So are we truly opening up access? And I think that'll just be something to continue to watch as adalimumab biosimilars rollout.

Recently, Abrilada was approved as the second interchangeable adalimumab biosimilar. How do you think the interchangeability label will influence payer preferences and prescription habits in the adalimumab space?

I do think that interchangeable ability makes it much easier. Obviously, you do not need to intervene and contact the provider to change the prescription over. However, I think that smaller community sites could come up with alternative mechanisms such as potentially collaborative practice agreements if their state state laws allow that and that would still kind of get over that operational hurdle of that interchangeability. 

But again, I don't know that they don't necessarily have a huge impact on insurers uptaking biosimilars. I think they're probably going to be focused more on does the delivery of device match what that reference product is and what are those price points.

Videos

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, comments on concerning data from Cardinal Health and Spherix Global Insights regarding the potential growth of the US adalimumab market, including providers’ views on interchangeability and payers’ influence on utilization.

, a Cardinal Health report found that over 60% of providers intend to only prescribe adalimumab biosimilars that have an interchangeability designation, indicating that providers consider interchangeability to be a significant safety identifier, despite this not being what the label means. Why do you think providers feels this way, and what more is needed to clarify the meaning of interchangeability?

Well, providers have been swayed over a number of years from a variety of different directions. Initially, the originators swayed providers by putting doubt into their mind regarding how similar a biosimilar really is. And in particular, as you mentioned earlier, in the absence of trials within inflammatory bowel disease, so there's been a sense of doubt that has been placed for many years. 

But the reality is that it's not going to be up to the provider. Because if a third-party payer decides to provide a biosimilar at a substantially lower cost to the patient, they're not likely going to pay the difference for what the biosimilar would cost them, which is usually nothing. Remember, patients are usually paying about $5 a month for adalimumab nowadays. If the patients actually have to pay for the drug, there's going to be a substantial cost difference.

 found that despite high awareness of adalimumab biosimilars options, uptake has been low so far. What more needs to be done to improve provider willingness to prescribe these agents?

It's not the willingness to prescribe, it's that the originator has negotiated pricing that is still favorable to third-party payers. Hence, the need to accept a biosimilar has been less than anticipated. But as we've seen, this will change over time as there is greater and greater acceptance and the multiple biosimilars will ultimately bring the cost of adalimumab down.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market

There are many steps that health systems can take to prevent the nocebo effect when transitioning patients from Humira (reference adalimumab) to an adalimumab biosimilar, according to Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University.

Can you discuss the importance of pharmacovigilance in populations with Crohn disease and ulcerative colitis since there haven’t been many studies evaluating adalimumab biosimilars in these patients?

Pharmacovigilance studies for any specific biosimilar are going to be quite a challenge, because it's likely that, [for example,] third party A will pick biosimilar 1 for a year and then, because of changing costs may pick biosimilar 2 or 3. So I believe in this environment. There's going to be a lot of switching between the different agents, which means that pharmacovigilance of a single agent is going to be much more challenging.

How do you think the Crohn disease patient community is responding to adalimumab biosimilar options and the potential for more nonmedical switching from the reference agent to a biosimilar? Are you fearful of the nocebo effect for these patients?

That's the most challenging question, because patients see the medicine as their medicine; for instance, "my Humira." One of the worst things that you can do in social psychology is take something away from an individual. And if you're taking away "their Humira" and substituting something else, they perceive that as not necessarily being good—often as being bad.

So, we need to be able to circumvent that concept that feeds into the nocebo effect, which is going to be accomplished by having the biosimilar company not just having a biosimilar product but having it perform and be administered in the same or easier ways [as the reference product.] For instance, there may be better injectors available for individuals that might be easier [to use]. It will be important for patients who are using citrate-free products to have a citrate-free formulation available to obviate worsening symptoms with injections or injection site reactions.

And then all the other services that have come with the originator, with Humira from AbbVie, need to be replicated for each and every biosimilar for it to be acceptable to the patient. So, the presence of having nurse navigators or ambassadors present, for having assistance programs available, and all the other services to patients are really going to be needed in order to prevent this nocebo effect.

Another important concept is cognitive dissonance. In other words, the more effort somebody puts into something, the more perceived benefit, and that includes costs. So that's why if someone sees 2 identical sweaters and 1 cost more than the other, they tend to like it better. And so substituting a less costly [option] may be perceived as less beneficial or less effective.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, discusses why providers need to be wary when deciding whether patients with Crohn disease should switch from Humira (reference adalimumab) to an adalimumab biosimilar.

Dr Stephen Hanauer Weighs In on Pharmacovigilence, Nonmedical Switching in Crohn Disease

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, highlights the importance of his study comparing an adalimumab (Cyltezo) with the refrence product (Humira) patients with gastroenterology conditions.

What role can your trial play in improving patient and provider confidence in using adalimumab biosimilars for Crohn disease and ulcerative colitis?

The study actually provides additional reassurance regarding the biosimilarity and the potential of patients switching from either the [reference product] to the biosimilar or substituting the biosimilar from the onset.

Why are more clinical studies on anti-TNF [tumor necrosis factor] medications in gastroenterology conditions needed and how can providers and health systems be better advocates for these types of trials? 

Firstly, there still is room for improvement in efficacy within the TNF class. We're not getting 100% remission rates and we know that remission rates can be improved with the addition of immunomodulators for instance, or dose escalation in some situations. In addition, we are seeing newer TNF formulations—for instance, of subcutaneous infliximab—as a maintenance therapy. So, as additional biosimilars are coming out, we also have additional new products of the same class that are being evaluated and offer patients different opportunities, for instance, of intravenous versus subcutaneous formulations at different intervals.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.

Dr Stephen Hanauer: Why More Studies Assessing Adalimumab Biosimilars in Gastro Conditions Are Needed

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, emphasized that although adalimumab biosimilars are new to gastroenterologists, this is not their first experience with anti–tumor necrosis factor (TNF) agents.

 that demonstrated the safety and efficacy of an adalimumab biosimilar (Cyltezo) in patients with advanced Crohn disease. As of October 2023, it is the only study assessing an adalimumab biosimilar in patients with inflammatory bowel disease, which is an umbrella term for Crohn disease and ulcerative colitis. 

With 8 adalimumab biosimilars now on the US market, how are gastroenterologists reacting to these new products and are there concerns about extrapolated indications for inflammatory bowel disease?

The 8 adalimumab biosimilars are not gastroenterologists' first experience with biosimilars actually. We've had some experience with infliximab biosimilars over the past several years. In reality, it's unlikely that most gastroenterologists are going to prescribe a specific biosimilar because they're so much dependent on third party payers and their individual preferences. So, I think it's more likely that gastroenterologists are going to order for instance, Humira [reference adalimumab] and accepted alternative biosimilar or use the term "adalimumab" and again, accept biosimilars.

How important is it to have trials for adalimumab products and other anti-TNF biosimilars tested in patients with gastroenterology conditions, especially when most of the other trials for these products have only been tested in rheumatoid arthritis and psoriatic arthritis populations?

Again, gastroenterologists, overall have accepted the regulations for biosimilars that allow for extrapolation. However, having individual studies with specific biosimilars do provide a little bit more reassurance, perhaps, that the performance is going to be as [similar to the reference product] as anticipated.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

Dr Stephen Hanauer Welcomes Adalimumab Biosimilars to the Gastroenterology Space

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, believes that adalimumab biosimilars will greatly impact the US health care system. However, whether interchangeable designations will affect the adoption of these products remains to be seen.

With states having different laws regarding interchangeability, new bills being introduced to Congress to eliminate switching study requirements, and only 4 biosimilars overall having an interchangeability designation, what is your view on the value of interchangeability?

Interchangeability introduces an additional cost. When the manufacturers are researching the medication during clinical trials, they are required to go through an additional step. And it's not just a little step; it's an extremely large step involving patients and clinical trials and millions and millions of dollars in additional costs to prove [basically] biosimilarity again, sort of. So, it's really kind of an extra step that's extremely costly, that is really just, again, proving that your medication is indeed the same thing as the reference product.

So I think the opinion that this is an extra, maybe unnecessary step is shared by many and that's why we're seeing these bills being introduced, and I think the bills make sense. They're very tactical. You know, “Here's what language we could remove from the 351(k) FDA approval pathway to kind of back that out and maybe simplify this process.” And not only simplify the process for manufacturers, but simplify the process for physicians, for prescribers, for pharmacists, and for the entire health care system.

Interestingly, for the one interchangeable biosimilar that we have in the adalimumab space today [Cyltezo], it is a higher-cost product. So I do believe that these additional clinical trials are unfortunately going to lead to higher costs being passed through to the product launch. And that's not really what any of us want to see. I love seeing these huge discounts that we're seeing on these new products with the low WAC [wholesale acquisition cost] strategies. And that's what we want to continue to see more of, and if we continue to add costs to the process to get the drug approved, it'll be more difficult for us to bring down this cost long term.

Do you think the interchangeable label will have an impact on adalimumab adoption or do you predict that adoption rates will be more like those in the interchangeable insulin space?

It's interesting; that's one of those kind of “predict the future” questions since we're still in early stages of this launch. However, Cardinal Health publishes a really nice 

, and we did publish one in 2023. And it did kind of clearly highlight that many providers prefer an interchangeability designation, in order to have a comfort level prescribing an adalimumab [biosimilar]. So even though we know this is a regulatory step, that is absolutely not a clinical designation. It's not a safety or efficacy designation; it's a regulatory designation only. Providers are being convinced that this may be a differentiator, and we do have some data supporting that—at least in the rheumatology space.

So will that impact market share? I think that will be determined in a lot of ways by the selections of the payers and the PBMs [pharmacy benefit managers] and the cost savings that's potentially passed to the patient. However, it's definitely not something that's going to hurt them at this particular point in time. I don't think that it is a bad thing to have interchangeability designation until we figure out as a country what we want to do with that longer term.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

Fran Gregory Weighs In on the Value of Interchangeability in the Adalimumab Market

Julie Reed, executive director of the Biosimilars Forum, explains the thought process behind launching adalimumab biosimilars at 2 wholesale acquisition costs (WACs), whether this pricing strategy actually helps patients, and if the United States will see it permeate into other markets.

Several of the companies that launched adalimumab biosimilars in 2023 chose to use a dual-pricing strategy, where the biosimilar was priced at 5% and 55% lower than the originator Humira. Why did these companies chose to do this and do you expect a similar strategy to be used for future launches in other highly-competitive markets?

Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.

Gastroenterology

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