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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

On this episode, we discuss the abundance of oncology news from November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

Biosimilar Oncology Roundup for November 2023—Podcast Edition

Articles

A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.

Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of November 27, 2023. 

The Top 5 Biosimilar Articles for the Week of November 27

The Center for Biosimilars® covered an abundance of oncology news during November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

Biosimilars Oncology Roundup: November 2023

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Business & Practice

At Asembia 2023 in Las Vagas, Nevada, Tasmina Hydery, associate director of Digital Solutions at AmerisourceBergen, presented on the future of the biosimilars industry as well as how payers have responded to the influx of new biosimilar products in the United States. During the session, she shared results from AmerisourceBergen's report on the biosimilars pipeline, sharing survey results on how payers place biosimilars on formularies, their views on interchangeability, and their use of prior authorization and step therapy strategies to encourage providers to prescribe preferred products.

On today's episode, we spoke with Tasmina and her colleague, as well as a returning guest on the Not So Different podcast, Brian Biehn, senior director of Biosimilar Commercialization at AmerisourceBergen, about some of the points brought up during the presentation and some of the pricing trends that we're seeing in the space.

To learn more about Tasmina's Asembia 2023 presentation, 

AmerisourceBergen Biosimilar pipeline report

To listen to Brian's past appearance on Not So Different, 

Asembia

On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.

What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends

Although the oncology space is well-known for having the most successful biosimilar uptake, there are barriers that remain. Community oncologists and patients still have to reckon with pharmacy benefit manager (PBM) and payer formulary decisions, incentives for prescribing reference products, and inflated drug prices. However, community oncology practices have a unique opportunity to help boost biosimilar adoption and create savings for patients.

Today, I’m joined by Mark Guyot, senior director of unity provider engagement at McKesson, to discuss some best practices for biosimilar implementation in community oncology practices. Mark worked on creating and conducting McKesson’s real-world analysis that identified challenges and provided necessary support and education for successful biosimilar adoption. The analysis also led to changes within community oncology practices, resulting in significantly decreased care costs for patients, as well as annual cost savings to Medicare, totaling over $164 million.

To listen to our podcast with Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars, 

On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.

How Community Oncologists Can Break Down Biosimilar Adoption Barriers

The newest field of health care to experience biosimilar competition is the ophthalmology space, particularly the retinal disease treatment sector. Currently, the United States and the United Kingdom each have 2 ranibizumab biosimilars and the European Union only has 3, all of which were approved in the last 2 years. Additionally, more ranibizumab biosimilars referencing Lucentis and a slew of aflibercept biosimilars referencing Eylea are expected to enter the market over the next few years. Although all data shows these products to be bioequivalent to their reference products, the lack of real-world evidence around the world has left many ophthalmologists and biosimilar experts struggling to gain clarity on the safety of these products.

Furthermore, there is even more confusion about the meaning of interchangeability after 1 ranibizumab product (Cimerli) was granted an interchangeability designation by the FDA despite the label only applying to products dispensed through pharmacies and the label being granted without requiring data from a switching study.

Today, I’m joined by Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, to discuss these issues and the FDA’s efforts to instill public confidence in ophthalmology biosimilars. Dr. Yim has worked extensively to help create the FDA’s education material on biosimilars and spread the FDA’s view that biosimilars are as safe and clinically effective as their reference products. 

Prior to her work at the FDA, she was a clinical fellow at the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Disease and served as a medical officer for the US Army for over 10 years. She also hosted the FDA’s workshop on increasing efficiency within biosimilar development programs, presented at the DIA Biosimilars Conference, and was a featured panelist for our most recent LinkedIn Live event on ophthalmology biosimilars last fall.

To check out part 1 of this interview series (written Q&A with Samsung Bioepis’ Kyung-Ah Kim), 

Coming soon, part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake.

To learn more about the approval of Cimerli, 

To learn more about ophthalmology biosimilars, 

To learn more about clinical efficacy testing, 

To learn more about our LinkedIn Live event on ophthalmology biosimilars, you can 

To check out the FDA’s overview page on biosimilars, 

To check out the FDA’s patient-focused biosimilar education materials (English and Spanish versions), 

To check out the FDA’s biosimilar education materials for health care professionals, 

For more information on the FDA's biosimilar curriculum, 

For more information on the FDA's free CE courses on biosimilars, 

 and use the filter function to select biosimilars.

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy

Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars

BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable

Biden Authorizes Update to the Biosimilar User Fee Act Through 2027

New Bill Aims to Remove Barriers to Interchangeable Biosimilars

Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years

It’ll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake

Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency

Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy

Biosimilars Policy Roundup for October 2022—Podcast Edition

On this week’s episode, we’re discussing the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and more payers add them to formularies.

I am joined by Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, and a member of The Center for Biosimilars® Advisory Board. She is an expert on the administration and practice perspective of managing biosimilars and has extensive experience supervising a practice that has had to adapt to the growing body of oncology biosimilars that have launched on the US market.

To read more of Kathy’s thoughts on the practice perspective regarding biosimilars, click 

To learn more about automatic substitution policies, click 

To learn more about some of the challenges clinicians could face next year as adalimumab biosimilars enter the market, click 

To learn more about prescription behaviors regarding biosimilars, click 

To listen to another podcast episode on a tool that can improve infusion center efficiency, click 

In this podcast episode, Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discussed the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and are added to formularies.

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

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

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

To see which biosimilars have been approved by the FDA, 

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

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

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

Patients in British Columbia, Canada, now have access to 3 new biosimilars for the prevention of blood clot disorders, all of which reference Lovenox (enoxaparin).

Redesca, Noromby, and Inclunox have been added to the list of reimburseable biosimilars covered by PharmaCare, the province’s public health plan. Noromby was developed by Juno Pharmaceuticals, Inclunox is a Sandoz product, and Redesca was developed by Valero Pharmaceuticals. Both the original and high-potency versions of the drugs are available for public reimbursement.

“We are very pleased to have secured public coverage for Redesca in British Columbia while its originator enoxaparin has been simultaneously delisted. Our biosimilar is now covered in every province, and it is already our best-selling drug. We anticipate further upside going forward now that it is publicly fully covered and that hospitals across the country are making the step to move to biosimilars LMWH [low molecular weight heparin]," said Frederic Fasano, president and chief operating officer at Valero, in a company 

Enoxaparin is a LMWH that acts as an anticoagulant medication for the treatment and prevention of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism both during pregnancy and following certain types of surgery. It is also used in patients with acute coronary syndrome and history of heart attacks and can serve as a replacement to oral blood thinners when other treatments for noncancer-related VTE have failed.

British Columbia is 1 of the 5 provinces and 6 jurisdictions that have a biosimilars 

 that enables reference products to be automatically substituted with a biosimilar version. British Columbia 

 its policy in November 2019, and in August 2020, it moved into the 

 of the program, which included the addition of 3 rituximab biosimilars to its list of options for patients to switch to from Rituxan.

 on November 30, 2021, which involves switching patients with type 1 or type 2 diabetes who are on or are scheduled to start therapy with the originator insulin lispro (Humalog) and insulin aspart (NovoRapid). By May 29, 2022, all patients will either have to switch or start therapy with biosimilars Admelog (insulin lispro) or Trurapi (insulin aspart) or risk losing coverage.

“Our government’s biosimilars program continues to help people in British Columbia save money by accessing more treatment options that are less expensive than the originator drug and are just as effective….The new biosimilars we are announcing will be of great assistance to those who develop blood clots, which can be deadly,” said Adrian Dix, Minister of Health, in a 

British Columbia officials specified that because enoxaparin is used in patients for less than 6 months, patients who are currently administered the reference product will not have to switch to a biosimilar and will be able to continue with their Lovenox prescription until their treatment course is complete.

Therefore, only patients who need to start a new enoxaparin treatment course will be administered a biosimilar. Exceptions may be granted for patients whose providers conclude that they are medically unable to take the biosimilars and whose exceptional coverage requests are approved by PharmaCare’s Special Authority branch.

Additionally, PharmaCare is updating how it provides coverage for treatments associated with cancer-related thrombosis, allowing patients with cancer to access dalteparin, enoxaparin, and tinzaparin without needing to try blood thinner warfarin first.

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

Blood Clot Prevention Biosimilars Achieve Reimbursement in British Columbia

In the United States, biosimilar uptake has been slow, largely owing to 2 major concerns: that discounts for biosimilars are not substantial enough yet to contribute to significant savings and that physicians and patients are not fully convinced that biosimilars are as safe and effective as their reference product counterparts. Although there have been plenty of clinical studies and analyses to support the savings potential and comparative safety and efficacy of biosimilars, many are still looking for real world evidence.

We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, an associate editor for the Journal of the Advanced Practitioner in Oncology, and an assistant professor at the Mayo Clinic School of Medicine, to discuss his real world experience incorporating biosimilars into his practice and how he addresses concerns about biosimilars.

To listen to part 1 of this podcast, click 

To learn more about building physician confidence in biosimilars, click 

For more on how switching to biosimilars can impact budgets and savings, click 

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, talks about the savings that biosimilars have brought to his practice and how he tackles patient and physician concerns over whether biosimilars work  as well as reference products.

Not So Different: How One Practice Is Addressing Biosimilar Concerns Over Savings, Safety, and Efficacy

Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences?

We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, Zarxio, a filgrastim product developed by Sandoz. Paul helped explain these issues.

To hear more from Paul on biosimilar issues, click 

To read about Paul’s insight on the current issues in the Indian biosimilar market, click 

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert, explains the relevance of differences between biosimilars and reference biologics. 

Not So Different: Should Biosimilar Variations Be Concerning?

On this week’s episode, we sat down with David Senior, senior vice president of Market Economics at AmerisourceBergen. We discussed how the generics market developed in the United States and some of the challenges that it faced. We also talked about how the US generics industry could be instructive in understanding how biosimilar sales may develop over time.

To learn more about the Hatch-Waxman Act, click 

To learn more about how biosimilars compare with the generics market, click 

To learn more about the challenges that both the biosimilars and generic markets face, click 

On this week’s episode of Not So Different, we spoke with David Senior, senior vice president of Market Economics at AmerisourceBergen, about the development of the generics market and how this could be instructive in understanding how biosimilars sales may develop.  

Not So Different: What the Generics Industry Can Tell Us About the Future of Biosimilars

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.

HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain

The legal and common uses of “interchangeability” continue to be conflated.

Confusion Persists Around the Interchangeability Designation for Biosimilars

Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.

BioRationality: FDA Publishes Results of First Meta-Analysis to Conclude All Biosimilars Are Interchangeable

Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.

Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate

global biosimilars week webinar in partnership with IGBA

Where Do Biosimilars Fit into the Cancer Treatment Puzzle?

The incidence of cancer is expected to increase to 30 million patients worldwide by 2040. However, the introduction of biosimilar medicines, both as treatment and supporting therapy for cancer patients, has created a significant opportunity to make cancer care more accessible, thereby improving patient outcomes and reducing the health care burden globally.

Everyone across the world involved in the fight against cancer—including patients, health care workers, policymakers, and governments—was invited to take part in IGBA’s Global Biosimilars Week 2023 webinar. During the event, discussions focused on how all stakeholders could collaborate to expand global cancer care, with a special emphasis on the role of policies related to biosimilar medicines.

IGBA’s fourth annual Global Biosimilars Week (GBW) is taking place from  November 13-17, 2023. The mission of this online, social media–focused campaign was to raise awareness of the powerful and life-changing impact of biosimilar medicines. The theme this year is "Making Cancer Care More Accessible to Patients and Healthcare Systems."

 is a proud media partner for GBW and collaborated with IGBA to host this webinar.

, cancer control officer, World Health Organization

, director of policy and advocacy, Lymphoma Coalition

, consultant pharmacist at The Royal Marsden NHS Foundation Trust and member of the International Society of Oncology Pharmacy Practitioners (ISOPP), United Kingdom

, member of the Biosimilar Medicines Committee, IGBA

Skylar Jeremias, senior editor at The Center for Biosimilars

In partnership with The Center for Biosimilars®, the International Generic and Biosimilar Association hosted a live webinar, where panelists gathered from around the globe to discuss benefits as well as major barriers and accessibility challenges associated with oncology biosimilars worldwide. 

Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle?

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.

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

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

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, believes that adalimumab biosimilars will greatly impact the US health care system. However, whether interchangeable designations will affect the adoption of these products remains to be seen.

With states having different laws regarding interchangeability, new bills being introduced to Congress to eliminate switching study requirements, and only 4 biosimilars overall having an interchangeability designation, what is your view on the value of interchangeability?

Interchangeability introduces an additional cost. When the manufacturers are researching the medication during clinical trials, they are required to go through an additional step. And it's not just a little step; it's an extremely large step involving patients and clinical trials and millions and millions of dollars in additional costs to prove [basically] biosimilarity again, sort of. So, it's really kind of an extra step that's extremely costly, that is really just, again, proving that your medication is indeed the same thing as the reference product.

So I think the opinion that this is an extra, maybe unnecessary step is shared by many and that's why we're seeing these bills being introduced, and I think the bills make sense. They're very tactical. You know, “Here's what language we could remove from the 351(k) FDA approval pathway to kind of back that out and maybe simplify this process.” And not only simplify the process for manufacturers, but simplify the process for physicians, for prescribers, for pharmacists, and for the entire health care system.

Interestingly, for the one interchangeable biosimilar that we have in the adalimumab space today [Cyltezo], it is a higher-cost product. So I do believe that these additional clinical trials are unfortunately going to lead to higher costs being passed through to the product launch. And that's not really what any of us want to see. I love seeing these huge discounts that we're seeing on these new products with the low WAC [wholesale acquisition cost] strategies. And that's what we want to continue to see more of, and if we continue to add costs to the process to get the drug approved, it'll be more difficult for us to bring down this cost long term.

Do you think the interchangeable label will have an impact on adalimumab adoption or do you predict that adoption rates will be more like those in the interchangeable insulin space?

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

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