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BIOSIMILAR APPROVALS

Articles

A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

Samsung Bioepis Report Signals Turning Point for US Biosimilars

Between congressional hearings and executive orders, experts had plenty to draw on when dissecting the barriers to biosimilar access at Festival of Biologics USA to close out April 2025.


Biosimilars Policy Roundup: April 2025

Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.

Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships

Cameron Santoro is an associate editor for The Center for Biosimilars

Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA. 

FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access

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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Clinical

Pegylated version (pegfilgrastim) Neulasta® is the more commonly prescribed agent, with a significantly longer half-life than its predecessor and is the preferred in patients receiving cancer chemotherapy.
 

Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in the Pipeline 

According to the authors of a paper published in Lancet Oncology, we may have gathered enough evidence to begin to consider altering how these agents are approved, to speed their path to approval.
 

Lessons From Europe: Is It Time for a Regulatory Course Correction?

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

Trastuzumab biosimilars saw significant market uptake in Japan after reimbursement incentives were implemented, but bevacizumab biosimilars did not experience a similar response.

Trastuzumab Biosimilar Adoption Increased in Japan Due to Reimbursement

During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.

Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

Bevacizumab biosimilars Mvasi and Zirabev provided cost savings for metastatic colorectal cancer (mCRC) treatment without compromising effectiveness.

Bevacizumab Biosimilars Reduce Costs While Maintaining Survival Outcomes in mCRC

Enhancing Biosimilar Adoption in Value-Based Oncology Care

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, highlighted biosimilars' role in making cancer care more affordable and accessible, especially for underserved populations. He stressed the need to balance cost-effectiveness with efficacy and called for greater payer trust in oncologists' biosimilar selections. Brewer also advocated for expanding "gold carding" to reduce prior authorization hurdles, promoting smoother biosimilar adoption in value-based care models.

This transcript has been edited for clarity; captions were auto-generated.

In a value-based oncology care model, what role do biosimilars play in ensuring equitable access to cancer treatments, especially for underserved patient populations?

Well, to the extent that you have, , biosimilars available, that that may be more cost effective, yet equally efficacious, relative to a particular treatment regimen, I think that goes a long way. Going back to the original cost-containment idea, so the more affordable you can make cancer care, the more accessible it is to to to broader populations.

That said, it's not always the best idea to just pick the cheapest if the cheapest isn't the best. You have to balance that with the efficacy of the treatment.

Can value-based oncology care models incentivize more rapid biosimilar uptake, and if so, what mechanisms should be in place to ensure their successful implementation?

That's really where the payers come in. We, as a practice, do a very good job of monitoring what's available on the market, what is the most efficacious, and then balance that with what is the most cost-effective. Unfortunately, at times we'll find that what we think the correct answer is, is not what the payer prefers, and the payer prefers brand B, C, or D.

And then it becomes a little difficult from a practice management perspective to keep on hand every "flavor" of biosimilar that's out there. I've told payers before we are not Baskin-Robbins. We don't carry all the flavors. That can lend itself to some conflicts with the payer.

So, I think the payers opening themselves up to trusting the community oncology providers a little more relative to the selection of biosimilars would go a long way in this space.

How do current reimbursement policies and payer models impact the integration of biosimilars into value-based oncology care, and what changes are necessary to promote their wider adoption?

I think opening up some of the prior authorization guidelines, more gold carding for trusted physician groups. I push for a gold card every chance I get, and I have absolutely no issue with with a payer coming back on the back end and saying, "Okay, well, let me take a look at 10- year files and see if it's not the fox guarding the hen house here."

We really are doing the right things for the right reasons. So, I think there's an opportunity to partner more with the payers on that front and get the payers to back off. And the best way to get them to back off is to show that we are consistently providing the highest-value care in the most cost-effective manner.

Videos

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

Tiago Biachi talking about GI biosimilars

During a recent interview at an Institute for Value-Based Care

Tiago Biachi, MD, PhD, assistant member at Moffitt Cancer Center and associate professor at the University of South Florida, emphasized that biosimilars are essential for enhancing the long-term sustainability of gastrointestinal (GI) cancer care by improving access to advanced treatments at lower costs.

He noted that rising health care expenses and the exclusivity of new drugs contribute to financial toxicity, significantly impacting patients’ quality of life. Biosimilars, particularly in cases of metastatic or advanced cancers requiring ongoing therapies, offer a pathway to equitable and affordable care. Biachi also underscored the importance of clinicians addressing treatment costs with patients and called for dynamic policies to streamline biosimilar development and adoption.

This transcript has been lightly edited for clarity.

How can biosimilars improve the long-term sustainability of GI care, especially in the context of rising health care costs?

Well, yeah, unfortunately, we're not doing a great job, for example, with screening or cancer in general. So if we don't screen for cancer, we're going to see more and more patients with advanced disease, where, usually, the treatment is more expensive. When we talk about new technologies, for example, for a diagnosis, or even new technologies for surgical treatment, of course usually they are going to add cost to the treatment. But usually the surgery, it's a 1-time procedure. Even, for example, circulating tumor DNA. Nowadays we have competition, with different companies providing this, and usually this is something that we're going to do every 3 to 6 months.

But when we're talking about drugs, usually once a new drug is released to the market, that company will have the right to commercialize that drug for a few years and we're not going to have competition with that. And usually, of course, new drugs are becoming more expensive. For metastatic disease or advanced cancer, for example, we're going to use this like, every 2 weeks or every 3 weeks, so biosimilars is probably the only way to be able to offer the best treatment for more people. And we're not talking about only about health care here in the US. So probably is the only way to be able to provide the same treatment [as] other countries.

With the increasing number of biosimilars entering the market, how can clinicians ensure that patients with GI cancers have access to more affordable treatment options such as these?

I think every time we're discussing treatment with the patient, we have to be mindful about cost. Sometimes providers don't think about the cost on the other end, and this is really important. Financial toxicity really matters. We have a lot of patients giving up on other aspects of their lives because [of the cost of] cancer treatment, and this is, of course, not good. As I said, biosimilars are one important aspect that can help a lot with this.

Of course, there are a lot of policies that we need to discuss because, as I said, once a company develops a drug, that company will have the exclusivity to commercialize that drug in the market for a few years. So after that period of time, we might have the opportunity to develop biosimilars, but usually, this process is very dynamic.

Tiago Biachi, MD, PhD, emphasizes that biosimilars are vital for reducing financial toxicity and ensuring equitable, affordable access to advanced treatments in gastrointestinal (GI) cancer care, while calling for dynamic policies and greater cost awareness among clinicians.

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