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

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

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

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

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

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

Videos

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

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market

Hi, I’m Skylar Jeremias for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.


Here are the top 5 biosimilar articles for the week of October 16, 2023.


Number 5: Continuous innovation is required in various technological aspects to 

 the challenges of vast clinical data, according to an article on navigating data integrity for generic drug approvals.


Number 4: Researchers of a literature review found 

 between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.


Number 3: Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as 

 influencing biosimilar uptake in the United States.


 (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).


 Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.


To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of October 23, 2023.


The Top 5 Biosimilar Articles for the Week of October 23

Panelists explore opportunities for biosimilars to manage inflammatory conditions. 

Transitioning to Biosimilars: Considerations for Providers and Payers

This is a video synopsis/summary of a panel discussion involving Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; Jamie T. Brogan, APRN; and Vibeke Strand, MD.

Haumschild asked Brogan about the key opportunities provided by biosimilars for inflammatory conditions, specifically seeking her insights on opportunities around adalimumab (Humira) biosimilar access and use for providers and payers.

Brogan responded that biosimilars provide cost savings opportunities through competition, which could free up health care dollars for other needed treatments. The VOLTAIRE trials with adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) included Crohn disease patients, providing indication-specific data to reassure providers. From the payer perspective, adalimumab biosimilar competition allows price negotiations and access to discounts off the originator price. Payers will need to adapt formularies and provide education to ensure successful adoption.

Haumschild agreed cost savings would be beneficial, but noted provider concerns around immunogenicity, switching limits, and product differences that require thoughtful education so that patients understand without getting overwhelmed.

Video synopsis is AI-generated and reviewed by editorial staff.

Transitioning to Biosimilars: Considerations for Providers and Payers 

Experts explore current and future use of biosimilars in dermatology, gastroenterology, and rheumatology.

Utilizing Recently Approved Biosimilars in Clinical Practice

This is a video synopsis/summary of a panel discussion involving Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and the Winship Cancer Institute; Alice B. Gottlieb, MD, PhD, clinical professor and medical director in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai; Bincy Abraham, MD, MS, professor of clinical medicine in the Academic Division of Gastroenterology and Hepatology at Houston Methodist Hospital; Jamie T. Brogan, APRN, nurse practitioner at Northwestern Medicine; and Vibeke Strand, MD, biopharmaceutical consultant and adjunct clinical professor in the Division of Immunology and Rheumatology at Stanford University School of Medicine.

The discussion focuses on the evolving landscape of biosimilars, specifically the role of adalimumab biosimilars, in dermatology, gastroenterology, and rheumatology. Gottlieb highlights the exclusive use of infliximab and rituximab biosimilars in her dermatology practice, expressing interest in upcoming adalimumab biosimilars and emphasizing the importance of interchangeability. Abraham, in gastroenterology, stresses the significance of maintaining stability for patients on adalimumab due to the potential consequences of disease flares. Strand, in rheumatology, anticipates the use of adalimumab biosimilars, emphasizing the preference for those with interchangeable designations and citing reassuring data on immunogenicity.

The panel discusses the impact of biosimilars on patient stability, with Haumschild underscoring the importance of avoiding complications or disease progression. The conversation covers the challenges of payer coverage decisions and potential switches to biosimilars. Brogan contributes insights into the auto substitution process, highlighting the need for shared decision-making and patient education.

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

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

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

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

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

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

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

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

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

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

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.


Number 5: No safety or immunogenicity differences were found in patients who 

 and those who continued on a reference biologic or biosimilar.


 found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.


 became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.


Number 2: Sarfaraz K. Niazi, PhD, chronicles how 

 (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.


Number 1: Boehringer Ingelheim (BI) launches an 

 of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.


The Top 5 Biosimilar Articles for the Week of October 16

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

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

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

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

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

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

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

Hi, I’m Justina Petrullo for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of October 9, 2023.

 he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.

Number 4: At EURETINA 2023, Samsung Bioepis shared 

 on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

Number 3: Boehringer Ingelheim (BI) launched an unbranded version of its 

 Alvotech and Kashiv Biosciences partnered for an omalizumab biosimilar candidate; the FDA issued a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

 developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Number 1: Pfizer’s Abrilada (adalimumab-afzb) became the 

second biosimilar referencing Humira (adalimumab)

 to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

The Top 5 Biosimilar Articles for the Week of October 9

Pfizer Global Biosimilars Commercial Lead, Roman Irsiegler, gives his thoughts on why a sustainable biosimilars market is critical for the healthcare industry, and what stakeholders can do to achieve it.

What is key to achieving a long-term sustainable biosimilars market?

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

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

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

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

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

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

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

Videos

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market

The Top 5 Biosimilar Articles for the Week of October 23

Transitioning to Biosimilars: Considerations for Providers and Payers

Utilizing Recently Approved Biosimilars in Clinical Practice

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

The Top 5 Biosimilar Articles for the Week of October 16

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

The Top 5 Biosimilar Articles for the Week of October 9

What is key to achieving a long-term sustainable biosimilars market?

Dr Stephen Hanauer Welcomes Adalimumab Biosimilars to the Gastroenterology Space