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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.

The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars

Early adopters of biosimilars have paved the way for broader acceptance by sharing real-world success strategies, overcoming initial resistance, and highlighting best practices for integration and cost savings.

How Early Adopters Are Shaping the Future of Biosimilars

In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.

Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of November 18, 2024. 

The Top 5 Biosimilar Articles for the Week of November 18

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Clinical

Navigating Next-Generation Therapies for the Management of Acid-Related Disorders

1.0 Credit / Gastroenterology, Immunology, Rare Diseases

Managed Care Insights on the Advances in the Eosinophilic Esophagitis Treatment Landscape

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars and the feasibility of switching to them.

Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars

DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use

Posters Demonstrate Switching Safety Between Originator, Biosimilar Infliximab in IBD

New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD

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

Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar

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

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.

Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition

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

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

In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.

Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD

A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD. 

Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab.

Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio, Market Reach

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, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.

Gastroenterology

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