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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.

Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings

At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.

Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars

The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.

Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches

Cameron Santoro is an associate editor for The Center for Biosimilars

A Korean survey found that while most oncologists believe biosimilars are just as safe and effective as originator drugs, they often prescribe the originators due to factors like lack of patient trust in biosimilars and lower than expected cost savings. 

Survey Finds Korean Oncologists Trust Biosimilars But Prescribe Originators More

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Clinical

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, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.

FDA Approves 10th Adalimumab Biosimilar, Simlandi

Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates

Vizient Report Emphasizes Biosimilar Successes, Impact of Inflation on Drug Spend

Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad

Eye on Pharma: Celltrion Biosimilars Win Tenders; Oral Ustekinumab Device Passes Phase 1 Trial

Analyzing Safety of Switching From Originators to Biosimilars: A Meta-Analysis of 21 Trials

Adalimumab Treatment May Impact Antibody Levels After COVID-19 Vaccination

Biosimilars Rheumatology Roundup for February 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

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

On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.


Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval

FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar

Multiple Infliximab Biosimilar Switches Appear Safe, Effective for Patients With IBD

Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo Effect

Spherix Global Insights: Despite High Awareness, Provider Comfort With Adalimumab Biosimilars Is Low

Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars

Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars

On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.



Biosimilars Rheumatology Roundup for April 2023—Podcast Edition

With 1 adalimumab biosimilar and 3 infliximab biosimilars on the market, and over 10 more biosimilars for rheumatoid arthritis (RA) coming down the pipeline, rheumatologists are about to have more treatment choices for their patients than ever before. 2023 marks the US introductions of biosimilar referencing Humira (adalimumab) and Stelara (ustekinumab). With an abundance of choice, come storage, education, and payer challenges. What can practices do to prepare? How can they boost uptake of these products? And how can we ensure that the lower than anticipated uptake of infliximab biosimilars is not repeated?

Today, I’m speaking with Robert Zutaut, RPh, clinical specialist with McKesson Provider Solutions about the influx of these RA biosimilars and actions that clinicians can take to prepare for the large number of products expected to hit the market in the next couple years. Prior to his work with McKesson, he served as the director of pharmaceutical services at Raleigh Regional Cancer Center in Beckley, West Virginia. He obtained a bachelor of pharmacy from West Virginia University and has been analyzing RA biosimilar trends and the everchanging market. He’s also been keeping an eye on the development for prognostic biomarker tests in the RA space.

To learn more about biosimilars to treat RA, 

To learn more about rheumatologists’ perceptions about RA biosimilars, 

To learn more about incentives for prescribing biosimilars, 

To learn more about infliximab biosimilar adoption, 

To learn more about the influx of adalimumab biosimilars to the US market, 

To learn more about ustekinumab biosimilars, 

Keep a lookout for Robert's upcoming contributor article on the developing RA biosimilar market.

What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.

2023 is gearing up to be a big year for biosimilars, especially in the United States, where up to 10 adalimumab biosimilars referencing Humira, one of the most expensive drugs in the world, will enter the market. In addition to that, we will see the fallout of major government policies, such as the Inflation Reduction Act and the Biosimilars User Fee Amendment, as well as how the market will respond to so many biosimilars entering the market at the same time. How will the first 6 months go? How will payers and pharmacy benefit managers (PBMs) alter their coverage options? Will interchangeability designations make a difference? Will biosimilars be able to get a greater piece of the market pie?

On this episode, Brian Biehn, senior director of biosimilar commercialization at AmerisourceBergen, explored how the new year may play out for biosimilars, including his predictions or how uptake will be influenced in the adalimumab market and how government policies will impact the competitiveness of the market.

To read more about adalimumab biosimilars, 

To read more about ophthalmology biosimilars, 

To learn more about the Inflation Reduction Act’s impact on biosimilars, 

To read more about the reauthorization of the Biosimilars User Fee Amendment, 

New Year, New Hurdles: What's in Store for Biosimilars in 2023

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?

On this week’s episode, we’re breaking down the possible impact that Humira biosimilars will have on health policies across the United States. Come 2023, the United States will welcome at least 7 biosimilars referencing Humira (adalimumab) to the market, catapulting the adalimumab market to the number 1 spot as the biosimilars space with the most competitive products referencing the same molecule. One of the biggest concerns regarding these launches is how providers, practices, and payers are going to adapt to ensure that patients have access to adalimumab biosimilars and that practices aren’t overwhelmed trying to keep up with multiple versions of the same product.

The Center for Biosimilars spoke with Chronis Manolis, senior vice president of pharmacy at UPMC Health Plan. He has a lot of experience working in the health plan space, especially regarding policy and relationships with pharmacy benefit managers, a rather contentious topic in present day biosimilar discussions. Manolis is also a proponent of the idea that providers and payers could work together to promote biosimilar use and has been keeping eye on the developing adalimumab space.

To learn more about the hype regarding adalimumab biosimilars in the US, 

To see which biosimilars have been approved by the FDA, 

To read more on PBMs and their influence on biosimilar uptake, 

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

Not So Different: How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.

Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment

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

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

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?

Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.

Videos

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Conference

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.

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.

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?

Unfortunately, yes. And we saw that with the Biocon Semglee [insulin glargine biosimilar] as well—they were forced to do that. Why they are being asked to do that is the product that only has the 5% discount, is a high WAC and highly rebated. So, they would—and I think most biosimilar manufacturers would—prefer to launch with the big discount. To get access to a formulary and access to the market, they're being required to put a high rebate on. And so the patient's out-of-pocket cost on a high rebate product are going to be based off of a 5% discount, not a 45% or 55% discount. That's not fair to the patients.

I think another piece, which is a concern—and we saw this before early in the biosimilars marketplace—we continue to see that the reference product, the brand is on the formulary at something called parity so everybody's equal. Well, biosimilars require incentives; there's a reluctance. [Patients think], "Well, if I think continue on my brand, why change?" And really, if it's a high rebated product, there's no incentive for the patient because they're out-of-pocket costs because of the rebate are not going to be lower. So I think that's key.

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.

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