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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

A Japanese study found high remission and continuation rates, plus non-inferior trough levels, after patients with IBD were switched to the infliximab biosimilar CT-P13.

Infliximab Biosimilar Maintains Remission, Trough Levels After Switch in IBD

Brooke McCormick is an assistant editor for 

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care.

Biosimilar Denosumab Could Reshape Access, Costs in Osteoporosis Care: Edward Li, PharmD

Bevacizumab-to-biosimilar-to-branded transitions delayed nAMD care and cost more than direct switches.

Step Therapy to Biosimilars, Branded Anti-VEGF Costs More, Data Show

A study found no direct trial evidence for natalizumab or its biosimilar in MS and found limited cost-effectiveness vs most alternatives.

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Clinical

Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).

Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab

Welcome to another insightful episode of Not So Different: a Podcast from The Center for Biosimilars. In this episode, we bring you detailed coverage of the trends, challenges, and insights gathered from the Festival of Biologics USA. 

Your host, Skylar Jeremias, assistant managing editor of The Center for Biosimilars

, and guest Dracey Poore, director of biosimilars at Cardinal Health, delve into the crucial themes that emerged from the conference discussions, mainly, the essential role of sustainability in the biosimilar industry. You'll hear about the forward thinking vision of the biopharmaceutical sector, as they maneuver through the evolving biosimilar landscape in their quest to make critical medications accessible to patients.

The conversation travels deeper into the biosimilar ecosystem as Poore explains the effect of significant challenges obstructing the widespread adoption and affordability of biosimilars. 

With insights from the richly detailed Cardinal Health Biosimilar Report, Jeremias and Poore guide you through the evolving prescriber trends and insights that influence biosimilar adoption alongside constructive strategies to overcome these hurdles. This episode sheds light on the importance of ongoing education, dismantling access barriers and promoting a competitive biosimilar market for a better health care landscape.

To read our coverage of the Cardinal Health report, 

To check out The Center for Biosimilars coverage of Festival of Biologics USA, 

00:03:48: Discussion on Cardinal Health Biosimilar Report and challenges to biosimilar adoption

00:04:48: Best practices for managing biosimilar inventories

00:08:05: Legislative efforts impacting the biosimilar landscape

00:10:38: Impact of payer preferences for reference products over biosimilars

00:13:36: Concluding thoughts on the future of biosimilars

Cardinal Health

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report

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

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

On this episode, we’re giving a rundown of some of the biggest stories in the immunology space regarding biosimilars, like the launch of 7 adalimumab biosimilars, the release of multiple market trend reports, and clinical trial results on traditionally bypassed disease states.

First Round of Adalimumab Biosimilar Launches in July

Celltrion Launches Yuflyma on the US Market

US Welcomes Idacio, Hulio to the Adalimumab Biosimilar Market

Will the Entry of Adalimumab Biosimilars to the US Market Successfully Lower Spending?

Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?

Despite Steep Discounts, Humira Biosimilars Are Priced More Than Original Originator Price

Price Reductions of TNF Inhibitors Across Europe After First and Second Biosimilar Launches

Multiple Infliximab Biosimilar Switches Were Safe, Effective

Adalimumab Biosimilar Improved Symptoms for up to 48 Weeks in Ankylosing Spondylitis

Biosimilar, Innovator Romiplostim Comparably Safe and Effective

Biosimilars Immunology Roundup for July 2023—Podcast Edition

On this episode, we’re going to be recapping some of the biggest stories in the immunology space regarding biosimilars, including a new European approval, ustekinumab biosimilar delays, and more.

FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar

Celltrion Launches Biobetter in Brazil, Shares Phase 3 Plan for MS Biosimilar

Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J

Dr Colby Evans: The Managed Care Perspective on Biosimilars in Immunology

Dr Vibeke Strand: The Current State of Immunology Biosimilars and the Promise of Future Savings

Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption

Biosimilars Business News Recap: A New Partnership; Celltrion Wins Tenders

Tocilizumab Biosimilar LZM008 Demonstrates PK Equivalence in Healthy Participants

RWE: Rituximab Biosimilar GP2013 Effective in Patients With RA After Switching From Originator

On this episode of Not So Different, we recap some of the biggest stories in the immunology space regarding biosimilars, including a new European approval, ustekinumab biosimilar delays, and more.

Biosimilars Immunology Roundup for May 2023—Podcast Edition

Congress advances biosimilar bills as new data emerge on romosozumab, tirzepatide, and ustekinumab biosimilar development.

Biosimilars Round Up: July 2026

A 50-patient study found sustained platelet recovery and low thrombotic microangiopathy rates through 52 weeks of biosimilar therapy, with favorable safety.

Eculizumab Biosimilar Shows Durable Benefit in Long-Term aHUS

Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe.

Positioning Biosimilar Ustekinumab Early Reduces Burden on Spain's National Health System

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

Sophia Humphreys talks

In an interview, Sophia Humphreys, PharmD, discusses how the expansion of biosimilars into new therapeutic areas, such as immunology, endocrinology, and ophthalmology, has led to increased hesitance compared to the quicker adoption seen in cancer treatment. This is due to the maintenance nature of many therapies, making it harder to switch patients to biosimilars. 

She emphasizes the need for patient and provider education about the safety, efficacy, and similarity of biosimilars. When addressing adalimumab biosimilars, Humphreys highlights factors such as product formulation preferences, interchangeability regulations, and payer coverage as key drivers in market competition.

This transcript has been edited for clarity.

How do new therapeutic classes and indications for biosimilars influence market expansion?

I think this goes beyond just patient education. And, for example, when we started with just the cancer curative and supportive agents, biosimilars, those are quickly adopted, and once we start to move into immunology, endocrinology and ophthalmology, now we started to observe more hesitance. 

One reason is because a lot of these are maintenance therapies. So we're not looking at starting a new treatment plan or starting a new cycle treatment with a new biosimilar. We're looking at convincing a patient who has failed several therapies before they reach the [reference] biologics now that could convince them to switch to a biosimilar product. So the first thing is that we really wanted to educate both our patients as well as our providers that these products are highly similar to the reference product. 

There's no evidence of diminished efficacy or increased immunogenicity or safety signals so far. For the past 10 years, we have used biosimilar successfully. And also we really wanted to address our health care system leaders that these biosimilar product in the expanded therapeutic classes would really increase access of care—really providing life saving, life altering medications for more patients.

What are the key factors driving competition among adalimumab biosimilars in the market?

Adalimumab, that's everybody's favorite molecule since July of 2023. So, several factors. This is actually quite similar—adalimumab and infliximab. It's almost similar. For autoimmune disease, as we have mentioned, a lot of patients are on maintenance [therapies]. And adalimumab has so many product [options]. And you really want to see if the product can match the existing product that our patient are using as much as possible. 

For example, if my patient is using a citrate-free product, you probably don't want to switch them to a product that is not citrate-free, which will cause probably more injection site discomfort. And also, a lot of patients prefer higher concentration vs lower concentration. That's another concern. And interchangeability is another concern. 

In a lot of states, we allow pharmacy-level switch, which means when a physician's order is the reference product for adalimumab in the state where they allow pharmacy-level switch, a pharmacist can switch the particular product to a interchangeable biosimilar of the reference adalimumab without a new authorization from the physician who prescribed that originator, because this particular product is interchangeable. 

Of course, different states have different regulations, and you also need to make sure that you meet the communication and information sharing requirement of your state, which means the patient needs to know that you're giving them a different product. The physician would need to know when you did the switching and which product was provided to the patient. Of course, most importantly, we need to know if the biosimilar you are switching to is covered by the patient's payers, and if they provide similar or comparable patient support and especially copay assistance. 

And when we are working with 340B-eligible sites, you would need to consider the switching effect to your 340B accumulation. So, a lot of factors are brought into this consideration. It's a very comprehensive analysis.

Videos

Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.

Addressing Hesitance in Biosimilar Adoption

Insights From Cencora's Lakesha Farmer: Innovative Biosimilar Adoption Strategies

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, explains new strategies being used to incentivize biosimilar adoption and market competition in a world where reimbursement and rebate policies cater more towards innovator products.

Can you discuss any innovative pricing and reimbursement models that have been implemented to incentivize biosimilar adoption and market competitiveness?

Sure, since the introduction to the market, we've seen some very unique pricing incidences strategies created to incentivize adoption of biosimilar agents. So, most recently, we've seen manufacturers take a nonbranded and branded approach to the launch of their biosimilars, which offers a low wholesale acquisition costs are WAC and the high WAC option. This pricing approach is currently being seen with insulin biosimilars and adalimumab biosimilars.

For example, the adaIimumab biosimilars Cyltezo was initially launched as a branded, high WAC product that offer about 5% discount to the originator (Humira). The makers of Cyltezo saw that the uptake of the medication was pretty slow, and that not all PBMs [pharmacy benefit managers] and insurers were receptive to adding the slightly discounted medication to their formularies. So, about 3 months after their launch, the manufacturer decided to launch an unbranded, low WAC version of the medication, which was surprisingly about 81% less than the originator product's price. So, by taking this low WAC/high WAC approach to pricing, this caters to all PBMs and issuer plans based upon their preference and increases coverage and access to biosimilar for patients.
The only possible downside to this pricing strategy that I can possibly foresee is that the heavily discounted low WAC options could possibly impact a manufacturer's ability to offer co-pay assistance programs and other patient access resources.

The second unique pricing strategy that incentivizes patients access to biosimilars is the Mark Cuban Cost Plus Program. This program aims to lower patient out-of-pocket costs by offering your Yusimry, an adalimumab biosimilar, to patients for a low cost of $569 [per month]. According to Drugs.com, the average cash price for Humira is about $7,300. As you can see, by offering this biosimilar at a cash price of $569 to uninsured patients, as well as a possible option for commercially insured patients with high deductibles, co-pays, and/or co-insurances can definitely be a game changer.

Now moving on to address the unique reimbursement incentive. Currently, the most notable incentive is the add-on payment for physician administered biosimilars that was introduced under the Inflation Reduction Act. Under this provision biosimilar reimbursement is set at ASP [average sales price] plus 8% of the reference product's ASP, which is higher than the reference product's reimbursement, which is set at ASP plus 6%. This higher reimbursement rate, provided through Medicare, provides community based providers with a greater incentive to use biosimilars for their patients.

Lakesha Farmer, PharmD, MBA, from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs.

Insights From Cencora's Dr Lakesha Farmer: Innovative Biosimilar Adoption Strategies

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.

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.

Unless pharmacy benefit managers (PBMs) stepping up to support biosimilars and provide broad access to these lower-cost products, the promised savings from ranibizumab and adalimumab biosimilars are going to develop slowly and a healthy competitive marketplace will be in jeopardy, said Juliana (Julie) Reed, executive director of the Biosimilars Forum, in an interview from Asembia 2023.

Although anticipated savings related to adalimumab and ranibizumab biosimilars are expected to develop over a long period of time, how long do you think the US will have to wait to see big price changes, and what needs to happen to ensure ample competition between products?

So I think that we could see immediate savings if the PBMs [pharmacy benefit managers] changed their model—they embrace biosimilars, they embrace competition, and they moved towards providing that and providing access. Otherwise, the savings will be slow. And it's not because [the Forum's] members did not develop or take all this time. If we have [9] biosimilars to Humira [adalimumab] is launching at 10 years of development, that's [90] years of development, and over $2 billion spent. And that's the concern—that all this time, these years, and all this money but PBMs won't provide access, and I mean preferred access. They need to support the industry. They need to support the competition. 

IQVIA and other economists have said that we could see close to $155 billion in savings by 2025. That's 2 years from now and that has a lot to do with those biosimilars launching. Those are real numbers and there's concern that those savings will not be realized. And I think the question will be why? Because we certainly we developed the biosimilars and we're bringing them to the marketplace, and we know they're safe and efficacious and approved by the FDA. So if we don't achieve those savings, the question is why, and we know that it's because we don't have access to the market and we're not able to compete.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

Immunology

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