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BIOSIMILAR APPROVALS

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Articles

BioRationality: No More Clinical Efficacy Testing for Biosimilars, Going From Biosimilars to Biogenerics

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

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability.

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

Laura is the editorial director of The American Journal of Managed Care

) and all its brands, including The American Journal of Accountable Care

, Evidence-Based Oncology™, and The Center for Biosimilars

, since 2011. She has an MA in business and economic reporting from New York University.

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.

Australian Study Reveals Significant Cost Savings and Market Impact From Biosimilars

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

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

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Clinical

The Economics of Transthyretin-Mediated Amyloidosis: Balancing Equity and Access in Resource Allocation

Innovations in Hidradenitis Suppurativa Treatment: Navigating the Evolving Landscape for Managed Care Professionals

1.5 Credits / Gynecologic Cancer, Health Equity, Diversity & Inclusion, Oncology, Women's Health

Advancing Immunotherapy in Endometrial Cancer: A Managed Care Perspective on Personalized Care

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

On this episode of Not So Different, The Center for Biosimilars

 discusses all the conference coverage, adalimumab data, and market insights to come out of the biosimilar dermatology space in March 2024.

AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars

Posters From AMCCBS and AAD Showcase New Technology for Biosimilar Uptake, Barriers to Self-Injectable Biologics

Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake

Adalimumab Expenditures in Countries With and Without Available Biosimilars

Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5

Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs

Cardinal Health Report Showcases Biosimilar Growth, Provider and Payer Evolution, and More

On this episode of Not So Different, The Center for Biosimilars® discusses all the conference coverage, adalimumab data, and market insights to come out of the biosimilar dermatology space in March 2024.

Biosimilars Dermatology Roundup for March 2024—Podcast Edition

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

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?

Shanghai Henlius Biotech is a growing China-based biopharmaceutical manufacturer that’s been working in the biosimilars space for some time. The company recently got approval for their 40 mg/ml low-concentration adalimumab biosimilar in December 2020 and is currently focused on marketing that in China. They have a plan to develop a high-concentration adalimumab biosimilar in the future to compete alongside AbbVie’s high-concentration formulation of the reference product, Humira. The company is also in the process of developing biosimilars for programmed death-1 (PD-1) inhibitors, which are used to treat several types of cancers.

We sat down with Ping Cao, vice president of Business Development for Henlius, to discuss the company’s current biosimilar development plans and how the regulatory process in China differs from those of Europe and the United States.

To hear more comments from Ping Cao, click 

To learn more about Henlius’ development plans, click 

To learn more about Henlius’ approval for their adalimumab biosimilar, click 

To learn more about PD-1 inhibitors, click 

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Not So Different: How Henlius is Making Its Mark on the Global Biosimilar Industry

A new biosimilar, SYSA1902, shows comparable efficacy and safety to ustekinumab for treating moderate-to-severe plaque psoriasis, expanding patient options.

SYSA1902 Biosimilar Proves Equivalent to Reference Ustekinumab in Plaque Psoriasis

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in patients who have rheumatoid arthritis, enhancing treatment accessibility.

Japanese Trial Supports Widespread Use, Safety of Infliximab Biosimilar Use

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab.

Biosimilar Business Recap: Updates on Tocilizumab, Omalizumab, and Ranibizumab Products

The MEGA-J study reveals CT-P13's long-term safety and effectiveness in treating inflammatory bowel disease and rheumatoid arthritis, with minimal adverse reactions.

Real-World Data Suggest Long-Term Safety of CT-P13 in IBD, RA

About 13% of patients who switch from Humira to an adalimumab biosimilar switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.

Adalimumab Double Take: The Unexpected Return to Reference Humira

Elena Wolff-Holz, MD.

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, supports automatic substitution of biosimilars at the pharmacy, citing that Europe often grants this immediately with marketing authorization. She highlights interchangeability in the US specifically refers to automatic substitution, and 

Wolff-Holz emphasizes the importance of patient education at the pharmacy, especially if a biosimilar involves a different administration device compared with the originator drug. She explains how pharmacists would be responsible for explaining these differences and stakeholders would highlight any distinctions and provide necessary educational materials.

This transcript was lightly edited for clarity; captions were auto-generated.

How do you feel about automatic substitution of biosimilars at the pharmacy level, and what safeguards do you believe are necessary?

I think automatic substitution at the pharmacy level is an option, it’s possible, it should be possible. I think this whole discussion on interchangeability that are granted in Europe immediately with the granting of the marketing authorization, and then at a national level, the automatic substitution can also be decided. Several countries, I think most recently, France, has accepted that, but other countries, also in Europe and in the United States, have a slightly different definition of interchangeability, in the United States compared with Europe. In the US, interchangeability really speaks to automatic substitution and if you can solidly justify that, and it is justified for Yesintek, so we've been granted the interchangeability status, then I think it's absolutely possible to do it. It's a clear, clear option.


I think what may have to happen is patient education also at the pharmacy level. If there were different devices, different ways that the drug would be applied, for example, also by the patient himself or herself, then it is important that the pharmacist takes on also the responsibility of educating the patient that there are maybe slightly different features in the apparatus, but it's not the drug, it's how you apply the drug. I think this is absolutely possible. I think we as a company, if there were differences to the originator, would then need to highlight this and bring out the materials, or make sure the pharmacist is aware of that. This could be an aspect, but so far, I don't think it is a problem.

What are the biggest misconceptions the general public has about biosimilars, and how can your research help to correct those misconceptions?

I think there could be an unfounded fear that something that is cheaper is less good, and that's why I don't like the word 

, because it's about affordability. These are more affordable; these are not cheaper products, but more affordable products. They are highest quality, they have to go through a very rigid regulatory process, and at the end of the day, they have been applied to human subjects. 

Our research has proven that. We've done all the analytics. We've done more than 100 orthogonal assays to look that really all the characteristics are the same. We've done a PK [pharmacokinetic] trial, where the dose curves are absolutely superimposable. Plus, we also did the phase 3 efficacy trials. Not only have we confirmed the analytical data with the PK trial, but also, all of those data with a phase 3 trial. There's absolutely no need to be fearful.


The other aspect is, I think, in the clever clinical trial design that we have, we've integrated the switch for those patients. Half the patients that were originally on Stelara, at week 16, they were rerandomized in a 1:1 split. Either they stayed on the Stelara or they then took the BMAb-1200 and we carefully monitored whether there would be a change in the effect or in safety or immunogenicity. We saw that there was no difference. Preswitch and post switch was not impacted, and all these are very solid data that really should ascertain and give the confidence to the patient, to the physician, and ultimately the payer, that these are high quality drugs.

Videos

Elena Wolff-Holz, MD, discussed the rationale and safety surrounding the automatic substitution of biosimilars at the pharmacy level, as well as common misconceptions about these medications.

Automatic Biosimilar Substitution and Patient Education Advocated by Elena Wolff-Holz, MD

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.

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

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.

Dermatology

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