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BIOSIMILAR APPROVALS

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The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

Omalizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

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

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

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

How Early Adopters Are Shaping the Future of Biosimilars

The oncology section is a comprehensive resource for clinical news and expert insights on oncology. Read more at the Center for Biosimilars.

Oncology | Clinical News & Insights | Center for Biosimilars

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On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships

Overcoming Economic, Noneconomic Barriers to Biosimilar Adoption in Oncology

EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions

New Data Show Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers

ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars

ASCO 2024 Posters Showcase Positive Data on Denosumab, Pegfilgrastim Biosimilars

Authors Spotlight Long-Term Solutions to Ensure Biosimilar Market Sustainability

Part 2: Unlocking the Potential of Biosimilars to Improve Health Equity

Biosimilars Oncology Roundup for June 2024—Podcast Edition

As 2023 comes to a close, we look back on some of the major advancements from the past year, from the long-awaited market introduction of adalimumab biosimilars in the US, to the first major regulatory approvals for neurology biosimilars, to the implementation of key policy initiatives around the globe.

A lot of eyes have been on the United States and 2024 shapes up to be another big year for the biosimilar industry, with approvals for denosumab, aflibercept, and on-body pegfilgrastim biosimilars on the way. Additionally, the nation will continue to see the fallout from the implementation of the Inflation Reduction Act (IRA), including its policies regarding Medicare price negotiations, as well as the role interchangeability designations will play into adoption rates. It also remains to be seen whether payers and pharmacy benefit managers (PBMs) are ready to embrace newer biosimilars and add them to formularies as preferred products, leaving the future for a sustainable biosimilar industry up in the air.

Today, I'm joined by Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and patient access, and policy insights at Cencora (formerly AmerisourceBergen). Both of them have been keeping a close watch on the biosimilar space throughout the year and today's discussion will surround how this year sets up a new chapter for the industry.

To learn more about the prospect for Neulasta OnPro biosimilars, 

To learn more about how the IRA will impact biosimilars, 

To learn more about the dual-pricing strategy being used for adalimumab biosimilars, 

To hear Brian's insight into how the ophthalmology biosimilar industry is developing, 

To listen to previous Not So Different episodes featuring more of Brian's insight into how the adalimumab market will develop and biosimilar pricing trends, 

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond

On this episode, The Center for Biosimilars

 we dive into the heart of the fourth annual Global Biosimilars Week. This event sheds light on the rapidly evolving landscape of biosimilars and their critical role in transforming the health care industry.

Now, you might be wondering, what is Global Biosimilars Week all about? Well, it's an annual social media awareness campaign hosted by the International Generic and Biosimilar Association (IGBA), where experts, thought leaders, and industry pioneers are invited to discuss the latest advancements, challenges, and breakthroughs in the realm of biosimilars. The significance of this week goes beyond the surface. It's a catalyst for fostering collaboration, driving awareness, and pushing the boundaries of innovation in biosimilar development. And today, we have a special guest who is at the forefront of this transformative wave in health care.

Joining us is Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health. As a returning guest on the podcast, Fran brings a wealth of experience and insights, particularly in the realm of oncology biosimilars—an area that holds immense promise for improving cancer care and making these crucial treatments more accessible. In fact, estimates project that the incidence of cancer is projected to surge to 30 million patients worldwide by the year 2040, underlying the need for more affordable treatment options for these patients.

In our conversation with Fran, we'll explore the dynamic landscape of oncology biosimilars, the challenges and opportunities in the growing biosimilar industry, and what we can expect on the horizon. So, buckle up for an enlightening discussion as we unravel the layers of biosimilars during this Global Biosimilars Week special.

For more information on Global Biosimilars Week, 

To read our article series in honor of Global Biosimilars Week, you can check out 

To watch the webinar The Center for Biosimilars collaborated with IGBA for Global Biosimilars Week, 

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, examines the evolution of the oncology biosimilar space in this special episode of Not So Different to close out Global Biosimilars Week 2023.


Global Biosimilars Week: Dr Fran Gregory Explores the Growing Oncology Biosimilar Space, Previews Future

2023 is gearing up to be a big year for biosimilars, especially in the United States, where up to 10 adalimumab biosimilars referencing Humira, one of the most expensive drugs in the world, will enter the market. In addition to that, we will see the fallout of major government policies, such as the Inflation Reduction Act and the Biosimilars User Fee Amendment, as well as how the market will respond to so many biosimilars entering the market at the same time. How will the first 6 months go? How will payers and pharmacy benefit managers (PBMs) alter their coverage options? Will interchangeability designations make a difference? Will biosimilars be able to get a greater piece of the market pie?

On this episode, Brian Biehn, senior director of biosimilar commercialization at AmerisourceBergen, explored how the new year may play out for biosimilars, including his predictions or how uptake will be influenced in the adalimumab market and how government policies will impact the competitiveness of the market.

To read more about adalimumab biosimilars, 

To read more about ophthalmology biosimilars, 

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

To read more about the reauthorization of the Biosimilars User Fee Amendment, 

New Year, New Hurdles: What's in Store for Biosimilars in 2023

This episode is going to take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar

https://www.centerforbiosimilars.com/view/fda-approves-stimufend-the-us-sixth-pegfilgrastim-biosimilar

FDA Approves Celltrion Biosimilar for Avastin, Vegzelma

https://www.centerforbiosimilars.com/view/fda-approves-celltrion-biosimilar-for-avastin-vegzelma

Oncology, Ophthalmology Biosimilars Progress in Europe

https://www.centerforbiosimilars.com/view/oncology-ophthalmology-biosimilars-progress-in-europe

Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application

https://www.centerforbiosimilars.com/view/biosimilars-check-in-canada-approves-third-etanercept-prestige-withdraws-trastuzumab-application

Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars

https://www.centerforbiosimilars.com/view/coherus-rep-previews-interchangeable-ranibizumab-adalimumb-launches-on-pro-competitor?seriesVid=5

Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts

https://www.centerforbiosimilars.com/view/policy-harmonization-clarification-could-aid-biosimilar-uptake-efforts

Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development

https://www.centerforbiosimilars.com/view/upcoming-who-guideline-changes-may-reduce-data-requirements-for-biosimilar-development

Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market Entry

https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-when-more-may-yield-less-price-erosion-of-biosimilars-following-us-market-entry

On this episode of Not So Different, we take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

Biosimilars Oncology Roundup for September 2022—Podcast Edition

This week’s episode is going to be recapping some of the biggest biosimilars news that happened over the past month. Much of the month focused on biosimilars used to treat patients with different types of cancer as well as whether patients and providers are being given adequate information prior to switching patients from a reference product to a biosimilar.

https://www.centerforbiosimilars.com/view/biosimilars-oncology-roundup-july-2022

https://www.centerforbiosimilars.com/view/denosumab-biosimilar-demonstrates-noninferiority-to-prolia-in-postmenopausal-osteoporosis

Alvotech’s pharmacokinetics trial for denosumab: 

https://www.centerforbiosimilars.com/view/alvotech-to-launch-pharmacokinetics-study-for-denosumab-biosimilar

Poster from the American Society of Clinical Oncology’s annual meeting: 

https://www.centerforbiosimilars.com/view/posters-assess-quality-of-trastuzumab-denosumab-biosimilars-in-cancer

https://www.centerforbiosimilars.com/view/henlius-pertuzumab-biosimilar-shows-similar-pk-profile-to-reference-product-in-first-human-study

Rituximab studies from the European Hematology Association Congress 2022: 

https://www.centerforbiosimilars.com/view/rituximab-biosimilars-prove-effective-in-large-b-cell-lymphoma

Survey on preparing patients and providers for switching to a biosimilar: 

https://www.centerforbiosimilars.com/view/survey-most-patients-received-inadequate-information-about-switching-to-a-trastuzumab-biosimilar

On this episode of Not So Different, we recap some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar. 

Not So Different: Biosimilars Oncology Roundup for July 2022—Podcast Edition

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

Despite some biosimilars, including those for filgrastim, trastuzumab, and bevacizumab, achieving a greater US market share than their originators, other biosimilar categories, such as pegfilgrastim and infliximab, are still trailing behind. Some biosimilar companies are becoming more savvy, developing new ways to make a bigger statement in the market.

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 what tactics biosimilar companies are using to better compete alongside originator manufacturers.

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

Not So Different: How Biosimilar Companies Are Stepping Up Their Game to Compete Against Originators

A major barrier to biosimilar adoption is physician hesitancy when it comes to prescribing these agents, especially in the oncology space. Physicians often want more clinical or real-world evidence on the safety and efficacy of biosimilars compared with reference products in patients with cancer, for whom the stakes are high when choosing a therapeutic or supportive agent. Additionally, some clinicians worry about having to stock multiple biosimilars for a single reference product. These may require different storage conditions and increase the risk of administering the wrong agent, creating financial risk for the practice.

We sat down with Gary Lyman, MD, MPH, an oncologist, hematologist, public health researcher, and long-time biosimilar advocate who has also helped develop guidelines in support of using biosimilars in the oncology space. We discussed what steps are needed to improve physician confidence in using biosimilars.

Gary Lyman, MD, MPH, an oncologist and hematologist, discusses some of the issues holding physicians back from prescribing biosimilars and some ways to ensure provider confidence in biosimilars.

Not So Different: Dr Gary Lyman Explains How to Ensure Physician Confidence in Biosimilars

Shanghai Henlius Biotech is a growing China-based biopharmaceutical manufacturer that’s been working in the biosimilars space for some time. The company recently got approval for their 40 mg/ml low-concentration adalimumab biosimilar in December 2020 and is currently focused on marketing that in China. They have a plan to develop a high-concentration adalimumab biosimilar in the future to compete alongside AbbVie’s high-concentration formulation of the reference product, Humira. The company is also in the process of developing biosimilars for programmed death-1 (PD-1) inhibitors, which are used to treat several types of cancers.

We sat down with Ping Cao, vice president of Business Development for Henlius, to discuss the company’s current biosimilar development plans and how the regulatory process in China differs from those of Europe and the United States.

To hear more comments from Ping Cao, click 

To learn more about Henlius’ development plans, click 

To learn more about Henlius’ approval for their adalimumab biosimilar, click 

To learn more about PD-1 inhibitors, click 

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Not So Different: How Henlius is Making Its Mark on the Global Biosimilar Industry

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

Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

Financial Incentives Boost Oncology Biosimilar Adoption, but Costs Remain Unchanged 

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.

Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share

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?

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

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, commented on how oncology practices can leverage their experience with oncology biosimilars and work with payers to increase biosimilar accessibility and improve adoption rates.

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, explains how oncology practices can work better with payers to increase biosimilar adoption and how those collaborations can be applied to other disease areas, such as immunology and neurology.

Oncology

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