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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Cameron Santoro is an associate editor for The Center for Biosimilars

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Here are the top 5 biosimilar articles for the week of November 25, 2024. 

The Top 5 Biosimilar Articles for the Week of November 25

Articles

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions.

Biosimilar Approval and Uptake Impacted by Global Regulatory Frameworks

Bevacizumab biosimilars have the potential to expand access and reduce costs without compromising patient outcomes in advanced non–small cell lung cancer (NSCLC)

Retrospective Study Shows Bevacizumab Biosimilar Efficacy in NSCLC

The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.

Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy

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Business & Practice

On today's episode, we'll dive deep into the US biosimilars market landscape, a topic of growing importance as biosimilars offer significant potential for reducing health care costs and increasing access to life-saving therapies. Understanding the current legislative and regulatory environment is crucial, as it shapes the approval and adoption processes for biosimilars. We'll explore key factors affecting payer uptake and provider adoption of biosimilars in the US, such as economic considerations, clinical evidence, and market dynamics. These factors are vital for stakeholders aiming to effectively navigate the complex biosimilars landscape. Additionally, we'll examine the challenges and opportunities associated with biosimilars for stakeholders across the health care continuum, including manufacturers, payers, providers, and patients. Addressing these challenges and leveraging opportunities can enhance the impact of biosimilars on health care systems and patient outcomes, making this discussion essential for anyone involved in the health care industry.

Today, we're joined by Kyle Noonan, PharmD, MS, is a highly qualified expert who supports scientific and commercial consulting engagements at Cencora, helping manufacturers demonstrate the clinical and economic value of their products. His work includes outcomes research strategy, pre-approval information exchange, payer value proposition development, primary market research, pricing research, and market access strategy.

Dr. Noonan has a diverse background with experience in various health care settings, including medical affairs within the biopharmaceutical industry, association management, consulting, and clinical trial research. He has extensive leadership experience with the Academy of Managed Care Pharmacy (AMCP) and has presented numerous posters at AMCP conferences. Dr. Noonan holds a Doctor of Pharmacy from Mercer University and a Master's in Pharmaceutical Outcomes and Policy from the University of Florida.

To learn more about Cencora and their efforts, 

To learn more about the Inflation Reduction Act's impact on biosimilars, 

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.








Biosimilars in America: Overcoming Barriers and Maximizing Impact

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

With 1 adalimumab biosimilar and 3 infliximab biosimilars on the market, and over 10 more biosimilars for rheumatoid arthritis (RA) coming down the pipeline, rheumatologists are about to have more treatment choices for their patients than ever before. 2023 marks the US introductions of biosimilar referencing Humira (adalimumab) and Stelara (ustekinumab). With an abundance of choice, come storage, education, and payer challenges. What can practices do to prepare? How can they boost uptake of these products? And how can we ensure that the lower than anticipated uptake of infliximab biosimilars is not repeated?

Today, I’m speaking with Robert Zutaut, RPh, clinical specialist with McKesson Provider Solutions about the influx of these RA biosimilars and actions that clinicians can take to prepare for the large number of products expected to hit the market in the next couple years. Prior to his work with McKesson, he served as the director of pharmaceutical services at Raleigh Regional Cancer Center in Beckley, West Virginia. He obtained a bachelor of pharmacy from West Virginia University and has been analyzing RA biosimilar trends and the everchanging market. He’s also been keeping an eye on the development for prognostic biomarker tests in the RA space.

To learn more about biosimilars to treat RA, 

To learn more about rheumatologists’ perceptions about RA biosimilars, 

To learn more about incentives for prescribing biosimilars, 

To learn more about infliximab biosimilar adoption, 

To learn more about the influx of adalimumab biosimilars to the US market, 

To learn more about ustekinumab biosimilars, 

Keep a lookout for Robert's upcoming contributor article on the developing RA biosimilar market.

What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.

Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars

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

Recently, Vizient, a member-owned health care consulting company, published the Winter 2023 edition of its Pharmacy Market Outlook Report. The report commented onthe current trends of the biosimilars market, including the impact that inflation and the COVID-19 pandemic are having on biosimilar utilization and drug prices as a whole. It also discussed the hotly-anticipated US launches of upwards of 8 biosimilars referencing Humira (adalimumab) that are expected throughout 2023 and how issues surrounding payer preferences and white bagging policies could influence the uptake of these products.

On this episode of Not So Differet, we spoke with Carina Dolan, PharmD, MS, BCOP, senior director for clinical oncology and pharmaceutical outcomes at Vizient. Prior to her role with Vizient, she served as a hematology and oncology clinical pharmacist at Baylor University Medical Center. In the past, she’s written for 

®, the written journal associated with our sister site AJMC.com, on the current opportunities and challenges for oncology biosimilars as well as how practices can evolve to better manage expensive immunotherapy options.

To learn more about Vizient’s Pharmacy Outlook Report, 

To read Dr. Dolan’s paper “Opportunities and Challenges in Biosimilar Uptake in Oncology published in 

To read Dr. Dolan’s paper “Evolving Practices in Managing Costly Immunotherapy” published in The American Journal of Managed Care®, 

On this episode of Not So Different, Vizient’s Carina Dolan, PharmD, MS, BCOP, expounds on some of the results from Vizient’s recent edition of its Pharmacy Market Outlook Report, including how inflation could influence biosimilar utilization.

On the Come Up: What Vizient’s Report Says About Inflation and Biosimilars

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.

Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency

On this week’s episode, we’re taking a look at the impact clinical teams have on biosimilar utilization and patient care within infusion centers. Many infusion medications are biologic drugs and juggling multiple biosimilars for the same reference product can place undue burden on infusion centers and result in medication errors, such as accidentally administering a product not covered by a patient’s insurance. Intrafusion by McKesson’s full management service enables better efficiency within infusion centers and relieves some of the pressure providers and administrators face when trying to manage infusion facilities, including leveraging biosimilars.

Today, I’m joined by Cheryl Vaughn, vice president of clinical services at Intrafusion by McKesson. She has worked closely to develop a robust develop the tool clinical nursing program that accompanies Intrafusion’s full management service and has been with the company for over 5 years. She also has over 8 years of experience working as a registered nurse prior to her time at McKesson.

To learn more about McKesson’s Intrafusion, 

To learn more about biosimilar storage concerns, 

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.

Tools of the Trade: How Intrafusion by McKesson Improves Infusion Center Efficiency, Biosimilar Utilization

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

In the United States, biosimilars can cause some concerns for patients and physicians who may not be fully versed in what biosimilars are. Because biosimilars are not the same as generic drugs, differ slightly from their originator products, and are often used in complex disease states like rheumatology, oncology, and ophthalmology, providers and patients may have the impression that biosimilars are less effective and safe than originators. Education is often seen as a pivotal tool in building confidence in biosimilars, as it can dispel myths and provide real-world information on the history and use of these products.

We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, to discuss how he has worked to build patient and physician confidence in biosimilars and what strategies worked best for his practice. Hanna is also an associate editor for the Journal of the Advanced Practitioner in Oncology and an assistant professor at the Mayo Clinic School of Medicine.

To listen to part 1 of this podcast, click 

To listen to part 2 of this podcast, click 

To learn more about building patient confidence in biosimilars, click 

To learn more about how education can improve patient confidence, click 

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, explains how his practice has worked to inform patients and providers about biosimilars and improve their confidence in the utilization of biosimilars.

Not So Different: Tactics for Increasing Patient and Provider Confidence in Biosimilars

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 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

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

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

Breaking Down Biosimilar Barriers: Payer and PBM Policies

Making the Cost of IBD Care Sustainable

By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options.

This year’s theme, "Advancing Access to Biosimilars," focuses on the progress made over the past two decades surrounding approval, market acceptance and adoption of biosimilars—as well as the challenges that remain in expanding access worldwide. With an effort to highlight the importance of collaboration among health care professionals, patients, stakeholders, and policymakers, the webinar will focus on 

 to advance access to biosimilars and will feature expert discussions on the key barriers to biosimilar uptake in different regions and explore strategies to overcoming these obstacles.



Current global trends in streamlining biosimilar regulatory requirements to foster efficient adoption and market growth.

Strategies to address challenges and improve biosimilar access.

The role of biosimilars in promoting health care sustainability and better patient outcomes.

, assistant managing editor of The Center for Biosimilars (host)

, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines (moderator)

, PhD, Executive Director for Products Evaluation and Standards Setting, Saudi Food and Drug Authority

, PhD, scientist, technical standards and specification unit group lead, norms and standards for biologicals, Health Product Policy and Standards/Medicines and Health Products/World Health Organization 

enior quality specialist, European Medicines Agency

, director, Office of Therapeutic Biologics and Biosimilars Office of New Drugs, Center for Drug Evaluation and Research, FDA

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

Sophia Humphreys, PharmD, talks about biosimilars

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, explains that biosimilar adoption relies on clear strategies in the "buy and bill" medical benefit space. Successful integrated delivery networks (IDNs) collaborate with group purchasing organizations (GPOs) and 340B programs, regularly assess cost factors, and integrate biosimilar tools into electronic health records (EHRs) to simplify prescribing for physicians. Prior authorization processes for both biosimilars and reference products also streamline care. Regular performance reviews and sharing results with leadership help drive continuous improvement in biosimilar uptake.

First, Humphreys notes that we need to differentiate between medical benefit and pharmacy benefit. Many of the most successful biosimilars are in the medical benefit space, especially in the "buy and bill" space. IDNs that work closely with GPOs, 340B branches, and formulary management teams perform regular reviews of coverage, patient mix, and average sales price vs acquisition cost. These analyses help them decide which biosimilars to prioritize. 

Additionally, some IDNs have built biosimilar tools into their EHR systems to streamline physician workflows. Physicians are extremely busy and can’t be expected to remember which product to use each quarter, so it’s important to build support into the system. Some IDNs have also incorporated prior authorization processes for both the reference product and biosimilars, further streamlining care. Finally, it’s crucial to conduct regular performance reviews and share success metrics with leadership. This continuous improvement process elevates the entire system.

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses how integrated delivery networks (IDNs) can help drive biosimilar adoption.

How Strategic IDNs Boost Biosimilar Adoption

Dr Lakesha Farmer Discusses Biosimilar Education

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, outlined educational resources on biosimilars that are already available to patients as well as how her organization ensures that patients are aware of biosimilars and are comfortable with switching products.

Could you share insights into patient and provider education efforts regarding biosimilars, and how these efforts have evolved to address misconceptions or concerns?

So as we know, education is one of the most important factors in the acceptance and adoption of biosimilars for both providers and patients. When I was in practice as a pharmacy administrator, the largest misconception I faced was that biosimilar studies were inferior to their reference products' because they utilized extrapolation studies to gain approval for all indications. In my role as the director of pharmacy and co-chair of the P&T [pharmacy and therapeutics] committee, I was responsible for educating my providers and nursing staff on how extrapolated indications were granted by regulatory bodies and how critical quality and analytical attributes were used to establish scientific justifications for biosimilarity and FDA approval. 

Also, while I was in that role, I worked closely with our physician leaders and nursing administrators to create consent forms for patients who were being switched from a reference product to a biosimilar. We made sure that thorough education was provided to all patients to ensure that they were all well aware of what a biosimilar agent was and to set the expectation that they would still receive the same level of high quality care with their new agent. 

Outside of resources being created internally at the practice level, there have been several educational resources created for patients and providers by external organizations like manufacturers, distributors, medical professional organizations, as well as the FDA. 

Now that I'm out of clinical practice and have the opportunity to sit on the other side of the table as a distributor and GPO [group purchasing organization] partner, my organization, Cencora, has also contributed to making sure our patients and providers are well educated by creating several educational resources for our downstream and upstream customers that can be found in our biosimilar information hub.

From a patient-centered perspective, what are some of the most important considerations when promoting awareness and acceptance of biosimilars as viable treatment options?

So as we all know, patients are at the heart of what we do. So more patient-centered approaches to improving patient care and increasing cost savings directly to the patient is going to be paramount. You would think that because biosimilars are provided at a much lower cost to providers that the cost to patients would also be much lower. Well, unfortunately, that's not always the case. 

Although biosimilar competition decreases the cost of the health care system, this does not always translate to lower out-of-pocket costs, especially for commercially-insured patients. 

Therefore, this highlights the need for more patient-centric and targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability directly to the patients who need affordable biologic agents for the treatment of their chronic and sometimes, unfortunately, life-threatening conditions.

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Conference

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

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. 

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