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April brought 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Biosimilars Policy Roundup: April 2024

During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.

Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability

The approval marks the sixth for a biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast and gastric cancers.

FDA Approves Henlius’ Trastuzumab Biosimilar, Hercessi

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.

Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar

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In today's episode, we'll be diving deep into the crystal ball, exploring predictions for how advancements from the past year will shape the biosimilar market in 2024 and beyond. With approvals, advancements, and regulatory shifts, the landscape of biosimilars is constantly evolving. And who better to provide us with insights into these changes than our returning guest, Julie Reed, executive director of the Biosimilars Forum?

We'll be delving into the impact of recent developments on market dynamics, discussing how these advancements are reshaping strategies, influencing investment decisions, and ultimately, transforming patient care. From the first on-body pegfilgrastim biosimilar to the growing acceptance of adalimumab biosimilars, we'll dissect the key trends and their implications for the future. But it's not just about looking back; it's about looking forward. Julie will be sharing her predictions for what lies ahead in the biosimilar market. What regulatory challenges can we anticipate? How will market access evolve? And what role will innovation play in driving the next wave of biosimilar adoption?

With Julie's expertise and insights, we'll gain a deeper understanding of the forces shaping the biosimilar landscape and uncover strategies for navigating the opportunities and challenges that lie ahead.

For more information on the Biosimilar User Fee Amendments III (BsUFA III), 

For more information on the 1-year anniversary of adalimumab biosimilars in the US, 

To listen to more of Julie Reed's thoughts on the US biosimilar industry and streamlining development, 

To learn more about the Biosimilars Forum, 

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.

Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024

On this episode, we discuss the biggest news to come out of October 2023, 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.

FDA Approves First Subcutaneous Infliximab Product

Abrilada Approved as Second Interchangeable Humira Biosimilar

Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future

Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart

Eye on Pharma: Another CRL for Alvotech; Cimerli’s Growing Market Share; BBCIC Awarded Grant

Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate

AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry

Biosimilar Business Roundup for October 2023—Podcast Edition

On this episode, we’re going to be giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.

Stelara and Enbrel Chosen for IRA Price Negotiation

Biocon Biosimilar Quarterly Sales Up 106%

STADA Earnings Project Record Breaking Profits for 2023

Despite Global Increase in Amjevita Sales, US Sales Dropped 63%

Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility

Cardinal Health Exec: How Adalimumab Biosimilars Can Reshape the US Health Care Industry

On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.

Biosimilars Business Roundup For August 2023—Podcast Edition

With US' market experience with biosimilars approaching a decade, industry experts are beginning to look into ways to accelerate biosimilar development to make more lower-cost products available to patients quicker. Strict regulatory guidelines require manufacturers to conduct numerous expensive and time-consuming preclinical and clinical trials to obtain approval and prove that biosimilars are safe and effective. However, research has shown that not all of these tests may be necessary anymore and there's might be ways to cut down on development spend without compromising safety.

A commentary paper written by 4 representatives from pharmaceutical companies sought to provide an unbiased perspective on this objective can be achieved, noting that extensive testing was needed when biosimilars were new but approval requirements should be updated as the industry gains new information.

Today, I'm joined by Julie Reed, executive director of the Biosimilars Forum, a nonprofit organization aimed at the advancement of biosimilar adoption through collaboration with biosimilar manufacturers. The companies that the paper's authors represent (Samsung Bioepis, Sandoz, Boehringer Ingelheim, and Fresenius Kabi) are all members of the Forum and our discussion with Reed will highlight some of the major pieces from the paper and next steps for the industry to propel biosimilar development into the future.

To register for the FDA's workshop on streamlining biosimilar development, 

To learn more about the Biosimilars Forum and its members, 

To read the IQVIA report cited in the paper, 

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.

How Streamlining Development Can Save the US Biosimilar Industry

On this episode, we’re going to be recapping some of the biggest stories in the business space regarding biosimilars, including adalimumab preparation, partnerships for commercialization, and more.

Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar

Roundup: Coherus Resolves AbbVie Dispute; Bio-Thera Solutions and Celltrion Expand Respective Partnerships

Eye on Pharma: First PBM to Cover Yusimry; Celltrion to Test Ocrevus Biosimilar; Another Stelara Settlement

The Age of Adalimumab Is Upon Us: How Stakeholders Can Prepare

Alvotech, Advanz Pharma Extend Partnership for Biosimilars in Europe

Medicare 340B Program May Be Reducing Biosimilar Uptake

Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030

Biosimilars Business Roundup for June 2023—Podcast Edition

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

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

Recently, Amgen released the latest update to its Biosimilar Trends Report, detailing some of the big successes for biosimilars in the United States since their market introduction in 2015 as well as current market trends, predictions for the next phase of biosimilar competition, and advice for stakeholders going forward. The report also gave insight into how biosimilar policies, such as reimbursement structures, could develop in the future and whether the United States is heading towards greater biosimilar adoption.

On this episode, I’m joined by Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen. Chad is a long-time friend of The Center for Biosimilars, having spoken to us in video interviews in the past about previous version of this report. He was also a recent panelist at the DIA Biosimilars Conference that was held in September 2022 and has been working with Amgen since 2000. He’s been working to advance biosimilars since 2014 and is considered a market expert on the biosimilars industry.

To read more about Amgen’s Biosimilar Trends Report, click 

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

To see more of Chad’s takeaways from older version of Amgen’s Biosimilar Trends Report, click 

To learn more about tender systems, click 

To check out the last episode of Not So Different, click 

Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen, discusses the most recent version of Amgen's Biosimilar Trends Report and what the report says about the current biosimilar market and how it could develop in the years to come.

What Amgen’s Biosimilar Trends Report Says About the Future of Biosimilars

 of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra; AVT02) in France, Germany, Finland, and Sweden, with more European countries to come.

The biosimilar to Humira will be offered to patients with rheumatic conditions in a 100-mg/mL high-formulation administered in a 40-mg/0.4-mL custom-designed prefilled auto-injector pen and as a 40-mg/0.4-mL or 80-mg/0.8-mL prefilled syringe.

 biosimilar, following its epoetin zeta, pegfilgrastim, teriparatide, and bevacizumab biosimilars. In addition to AVT02, Alvotech is developing an ustekinumab biosimilar representing Stelara, which has shown promise in 

 trials, and had partnered with BiosanaPharma for a 

“Although biosimilar medicines have been marketed in Europe for over 16 years, significant unmet needs exist for patients to access key therapies…. Positively impacting the lives of European patients with inflammatory disorders with our high-concentration, citrate-free alternative to Humira is fully in line with STADA’s purpose of caring for people’s health as a trusted partner,” said Bryan Kim, head of global specialty and executive vice president at STADA, in a statement.

AVT02 was granted marketing authorization in the European Union in 

 and has been approved in the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein, and Canada. In Canada, AVT02 is marketed under the name Simlandi. Besides Hukyndra, there are 9 other EU-approved adalimumab biosimilars: Amgevita, Amsparity, Hefiya, Hulio, Hyrimoz, Idacio, Imraldi, Libmyris, and Yuflyma.

Alvotech and its commercialization partner Teva Pharmaceuticals are seeking approval for AVT02 

 in the United States, where the biosimilar is under review.

“We are thrilled to take this important step with STADA into multiple European markets. The commercial partnership with STADA allows Alvotech to leverage its strengths as a purpose-built [research and development] and manufacturing platform, singularly focused on biosimilars, which are of vital importance for health care systems globally,” commented Anil Okay, chief commercial officer at Alvotech.

STADA Arzneimittel and Alvotech announced the launch of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra) in France, Germany, Finland, and Sweden, with more European countries to come.

STADA, Alvotech Launch Adalimumab Biosimilar in First Few European Countries

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

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

To listen to part 1 of this podcast, click 

To learn more about building physician confidence in biosimilars, click 

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

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

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

Formycon, a Germany-based biosimilar manufacturer, shared that its revenues for 2023 were 83% higher than in 2022, reaching a total of €77.7 million, according to its annual earnings report.

Formycon Reports 83% Revenue Increase in 2023

The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.

Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032

A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide); Celltrion completed its biologic license application for its omalizumab biosimilar candidate.

Eye on Pharma: Biosimilar Ozempic; Celltrion Omalizumab Biosimilar Submission

Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.

Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs

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?

Although a "generic-like" model may be preferable to stakeholders, the United States has a long way to go to get the biosimilars market to reach that point, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, at Asembia 2023.

Will the biosimilars space evolve into a more "generic-like" marketplace or will beiosimilars behave more like reference products?

Yeah, that's a really good question too! Right now, we are seeing biosimilars behave a little bit more like reference products. We're seeing them being treated differently on formularies. We're seeing them come to market with slight variations.

The adalimumab biosimilars are a great example of why they're not exactly like generics. There's variability in biologics in general. So, of course, there's variability in biosimilars. Not only is there innate variability, there's also some slight differences in some of the makeup of these products.

For example, with adalimumab, we have citrate-containing and we have citrate-free, we have high-concentration, we have low-concentration, we have different administrative devices that patients might view as better than others. So, there are a few things that are different about biosimilars and biologics in general that aren't present when we think about simple molecule generics that are all exactly the same.

While we would like biosimilars to look more like generics eventually, there are several things that we kind of have to evolve to get to that place.

I think that the FDA designation for interchangeable biosimilars is, to many people, confusing and somewhat unnecessary. And, we always hear it said that interchangeability of a biosimilar is a regulatory concern, not a clinical concern.

The fact of being approved by the FDA as a biosimilar in every other country in the world means it's an interchangeable biosimilar and it can be substituted for a reference product.

The United States is not there yet, on that piece as well. While I would love to say we're ready to really have a generic like model—I think that would be so much easier for all stakeholders—we're just not quite there in the US yet. There would have to be a lot of changes to policy, a lot of changes to the FDA approval processes and pathways, and we have a long way to go in that regard.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses what the future biosimilars marketplace may look like compared with generics and reference products at Asembia 2023.

Conference

Dr Fran Gregory Discusses the Future Landscape of the Biosimilars Marketplace

Hi, I’m Justina Petrullo 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 May 1st, 2023.

Number 5: Samsung Bioepis shared positive 1-year results from a phase 3 trial 

 between the company’s aflibercept biosimilar and the originator (Eylea) at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.

Number 4: In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and 

 that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Number 2: Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar 

 responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Number 1: Sarfaraz K. Niazi, PhD, dove into 

 may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of May 1, 2023. 

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