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

Videos

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?

Switching Patients from Reference Product to Biosimilar

This is a video synopsis/summary of a panel discussion involving distinguished experts Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; and Vibeke Strand, MD. The focus of this segment is on the crucial topic of transitioning patients from a reference biologic to a biosimilar

Abraham shares insights into her experiences with patients in gastroenterology who are being switched from a reference biologic, specifically adalimumab, to a biosimilar. The conversation highlights the importance of this transition, especially for stable patients who want to avoid flares. She discusses her limited experience with such switches, emphasizing that many patients starting on biosimilars are new to the therapy, having not previously used a reference product.

Abraham also shares a specific case of a patient who faced a loss of insurance, resulting in a treatment gap and subsequent flare when she went off the originator biologic, adalimumab. Because of cost considerations, Abraham restarted the patient on a biosimilar with a different concentration. She emphasizes the need to carefully assess concentration variations when making these transitions, particularly considering patient preferences.

The panelists acknowledge the impact of insurance decisions on switching decisions and stress the importance of effective communication to guide patients through the process. Abraham underscores the need for personalized approaches, considering factors such as age, needle aversion, and patient willingness to navigate the transition.

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

Insight surrounding the switch from reference drugs to biosimilars is provided by Bincy Abraham, MD, MS.

Initiating Biosimilar Treatment in Patients Without Previous Reference Biologic Experience

This is a video synopsis/summary of a panel discussion involving a multidisciplinary team of experts: Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; Jamie T. Brogan, APRN; and Vibeke Strand, MD. In this segment, the focus shifts to the initiation of biosimilars, particularly for patients who have never been prescribed the originator biologic.

Haumschild begins the conversation by underscoring the significance of the patient perspective in initiating biosimilars. He emphasizes the role of shared decision-making in this context, acknowledging that discussions might differ when initiating someone who has never received the reference biologic compared with someone who has experience with it.

Strand, an authoritative voice in rheumatology, offers insights into best practices for initiating biosimilars in patients unfamiliar with the reference biologic. She emphasizes the importance of shared decision-making and anticipates scenarios where providers may need to make informed decisions on behalf of patients. Strand highlights the critical role of explaining biosimilars comprehensively to mitigate the nocebo effect, emphasizing the need for patient education.

Vibeke Strand, MD, evaluates implementation of biosimilars in patients with no history of reference biologic use. 

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, provides an overview of biosimilars in the breast cancer space and lingering adoption barriers for oncology biosimilars.

Haumschild's comments came at the end of Breast Cancer Awareness Month and the beginning of Global Biosimilars Week, an annual biosimilar awareness campaign hosted by the International Generic and Biosimilar Medicines Association.

With October being Breast Cancer Awareness Month, what more is needed from providers and health systems to ensure patients have adequate access to biosimilars for breast cancer?

I think access to biosimilars is really important. It drives down the cost of care and I think allows more patients to be on treatment. But there's still some unanswered questions that exist. How do we get these biosimilars implemented into our EMR [electronic medical record]? What happens when some biosimilars are no longer covered by payers and we still want to utilize them? How quickly can we change a lot of our order sets? 

And then again, how do we educate some patients that might be concerned. They might be in curative intent. Do we have the proper education to make sure that patients understand that biosimilars are equivalent to the reference product and still provide great outcomes for them? Especially in their cancer journey for breast cancer. [We need to] let them know that they might interact with biosimilars throughout a variety of different treatment options, and they're still going to give durable responses.

I think once we get that education out, learn how to implement these biosimilars in a timely manner, we'll be a lot more successful, specifically in our breast cancer population.

What role can biosimilars for breast cancer play in improving breast cancer treatments overall?

I think biosimilars, again, will continue to provide more treatment options for patients at a lower cost. And I think that's a great thing. I think when you're creating more equitable access—you think about diversity, equity, inclusion in breast cancer—there's still a lot that we have left to accomplish. And so if we can leverage biosimilars, whether in combination or for supportive care, more patients can get on treatment or reducing the cost of the care to the provider. That's a great thing. 

When we think about value based care of breast cancer, we think about EOM [Enhancing Oncology Model] and some of those value-based care models, the more that we can leverage biosimilars and those frameworks. I think if we make more sustainable models of care, we can bring care out to the community or to patients directly

Also, can we consider [biosimilars for] home infusion or supportive care medications that patients can take at home? I think the more we can do that, and the more we make accessibility one of the key drivers, I think that's going to create better uptake for breast cancer patients as a whole and I think that's something to get excited about.

Studies have shown that oncology and supportive care biosimilars are the biosimilars with the highest market share and providers are very comfortable using these products. What are some of the main challenges still facing oncology biosimilars?

Biosimilars have good uptake now and I think there's a lot of excitement. Actually, I think oncology and maybe breast oncologist are one of the main leaders in adopting these therapies. But I think as we start to utilize them, we're seeing a little bit more difficulties, sometimes from the reimbursement side. So, if you look at net cost recover—if you're a large community oncology practice or health system—the average sales price continues to trend downward. And unfortunately, that's really difficult because that's the reimbursement for a lot of these practices. If there's no margin, there can always be the same mission. 

I think at the same regard, when we're utilizing these therapies, how many denials are we getting from our payer colleagues because we're not using the preferred biosimilar? And there's that slow down time to treatment. And when I think about breast cancer patients, we're really thinking about overall survival and progression free survival. So, every day and every minute counts for how quickly we can get them started on treatment. And the more we see delays there, I think that also influences treatment. 

Lastly, biosimilar uptake is important, but now we're seeing the reference products being reformulated to subcutaneous products. And so I think subcutaneous and a faster infusion sometimes might be more warranted, and then also kind of limits the growth of biosimilars into some of those therapeutic areas.

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, discusses the growth and continued challenges facing biosimilars used to treat breast cancer.

Dr Ryan Haumschild Draws Link Between Biosimilars, Health Equity in Breast Cancer

Here are the top 5 biosimilar articles for the week of November 6, 2023.


 found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.


 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.


Number 3: On this Biosimilars Roundup episode, we discuss the 

, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.


 to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.


 (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.


To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of November 6

Panelists discuss reference biologic and biosimilar concentrations as well as the importance of citrate-free, less frequent injectable medications. 

Biosimilar Administration Considerations Impacting Patient Experience 

This is a video synopsis/summary of a panel discussion involving a multidisciplinary team of experts: Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; Jamie T. Brogan, APRN; and Vibeke Strand, MD. The discussion delves into critical aspects of rheumatologic treatment strategies, providing valuable insights into evolving practices.

Haumschild initiates the discourse by emphasizing the advancements in biosimilars, focusing particularly on adalimumab (Humira). The discussion centers on concentration differences, with a spotlight on FDA-approved biosimilars featuring varying strengths. This prompts Brogan to elaborate on the practical implications, such as altered dosing regimens and the resultant impact on patient adherence. The transition to higher concentrations, notably in the gastrointestinal setting, emerges as a game-changer, reducing barriers and improving the overall patient experience.

The conversation takes an intriguing turn as Gottlieb sheds light on challenges in dermatology, addressing specifically hidradenitis suppurativa. Gottlieb introduces the off-label use of infliximab (Remicade), highlighting its potential efficacy in weight-based dosing. Notably, Strand brings attention to the differences in practice settings, emphasizing rheumatologists’ preference for self-administered subcutaneous therapies due to reimbursement issues associated with intravenous treatments.

Abraham underscores the significance of concentration in patient care, particularly in the context of gastrointestinal conditions. The transition to higher concentrations proves beneficial in addressing obstacles associated with invasive weekly medications.



Experts compare approaches to prescribing biosimilars over reference drugs.  

Decision-Making Process Surrounding Biosimilar Implementation

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 Gottlieb how she navigates choosing between a biosimilar or reference product for patients.

Gottlieb said most dermatologists prefer the reference adalimumab (Humira) given familiarity, as they lack education on biosimilar approval and interchangeability. She strongly prefers a biosimilar with interchangeability data and wants to know when patients switch. She would appeal for an interchangeable biosimilar over one without data. She also prefers a biosimilar studied in the disease being treated due to different outcomes and doses.

Strand disagreed, noting rheumatology patients frequently switch medications. Adalimumab is usually the first biologic, but then providers tend to switch to another agent after failure. Biosimilars will likely be first-line treatment, with little provider choice. Though interchangeability data is preferable, current biosimilars are highly similar without it. Providers rarely switch within a class, which limits adalimumab biosimilar opportunities. Prior authorizations are frustrating and may limit choices among the many adalimumab biosimilars.

Haumschild agreed providers should help select preferred therapies and interchangeable options. Provider comfort varies, but experience over time increases acceptance, as with bevacizumab.

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 30, 2023.

 in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still vary.

Number 4: Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the 

 of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.


 on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.


Number 2: In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the 

 and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.


Number 1: 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.


Here are the top 5 biosimilar articles for the week of October 30, 2023.


The Top 5 Biosimilar Articles for the Week of October 30

Providers speak to the importance of being knowledgeable of efficacy and safety data before prescribing biosimilars to patients.  

Provider Acceptance Driving Confidence in Biosimilar Therapy

Haumschild asked Abraham about the role of provider acceptance and confidence in biosimilars in driving adoption for inflammatory conditions.

Abraham said if a payer requires switching to a biosimilar, providers must comply regardless of confidence. However, provider knowledge of the biosimilar’s efficacy, safety, expected effects of switching, and so on allows confident counseling of patients concerned about changes in their medication for chronic disease. An informed provider can explain details to patients, reducing nocebo effects from anxiety about switching. Provider knowledge and confidence in biosimilars significantly helps adoption from the provider and patient standpoint.

Haumschild agreed that provider understanding of data enables confident prescribing and trust from patients, which has been crucial for biosimilar adoption. This transition of acceptance and confidence will be vital as inflammatory disease options expand.

Clinical and social challenges associated with biosimilars are discussed by key opinion leaders.

Navigating Challenges Associated with Biosimilars Across Various Disease States

Haumschild asked the panel about challenges providers are facing related to biosimilars for inflammatory diseases.

Gottlieb noted Medicare patients struggle most with drug costs, and substantially lower biosimilar pricing could greatly improve access for this population. With adalimumab (Humira) costing only about $5000 annually in Europe, almost no Medicare patients can currently afford a biologic in the U.S., he said. It is unclear if prices will decrease enough to really expand access.

Abraham said experience with infliximab (Remicade) biosimilars reduced potential challenges with adalimumab biosimilars in gastroenterology. However, with many adalimumab options arriving, differences between products in formulation, concentrations, and dosages must be considered to avoid confusion or lapses in treatment if patients are switched.

Strand noted uncertainty around which biosimilars payers will cover and how that will impact access. Formulation differences like citrate-free options can affect tolerability with weekly dosing. Medicare patients still have coinsurance and coverage gaps, creating financial toxicity that impacts adherence. Understanding overall cost impact for patients is difficult.