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WHEN CHOICE ARRIVES: Competition & Consequences

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Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.

Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings

At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.

Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars

The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.

Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches

Cameron Santoro is an associate editor for The Center for Biosimilars

A Korean survey found that while most oncologists believe biosimilars are just as safe and effective as originator drugs, they often prescribe the originators due to factors like lack of patient trust in biosimilars and lower than expected cost savings. 

Survey Finds Korean Oncologists Trust Biosimilars But Prescribe Originators More

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Business & Practice

On this episode of Not So Different, The Center for Biosimilars

 glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

FDA Approves Henlius’ Trastuzumab Biosimilar, Hercessi

Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval

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

AON Saves Over $243 Million With High Biosimilar Adoption

Julie Reed: Why 2024 Is Important for Biosimilars

The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability

Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion

Review Highlights Most Popular European Policies to Boost Biosimilar Uptake

On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Biosimilars Policy Roundup for April 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

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

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

The newest field of health care to experience biosimilar competition is the ophthalmology space, particularly the retinal disease treatment sector. Currently, the United States and the United Kingdom each have 2 ranibizumab biosimilars and the European Union only has 3, all of which were approved in the last 2 years. Additionally, more ranibizumab biosimilars referencing Lucentis and a slew of aflibercept biosimilars referencing Eylea are expected to enter the market over the next few years. Although all data shows these products to be bioequivalent to their reference products, the lack of real-world evidence around the world has left many ophthalmologists and biosimilar experts struggling to gain clarity on the safety of these products.

Furthermore, there is even more confusion about the meaning of interchangeability after 1 ranibizumab product (Cimerli) was granted an interchangeability designation by the FDA despite the label only applying to products dispensed through pharmacies and the label being granted without requiring data from a switching study.

Today, I’m joined by Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, to discuss these issues and the FDA’s efforts to instill public confidence in ophthalmology biosimilars. Dr. Yim has worked extensively to help create the FDA’s education material on biosimilars and spread the FDA’s view that biosimilars are as safe and clinically effective as their reference products. 

Prior to her work at the FDA, she was a clinical fellow at the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Disease and served as a medical officer for the US Army for over 10 years. She also hosted the FDA’s workshop on increasing efficiency within biosimilar development programs, presented at the DIA Biosimilars Conference, and was a featured panelist for our most recent LinkedIn Live event on ophthalmology biosimilars last fall.

To check out part 1 of this interview series (written Q&A with Samsung Bioepis’ Kyung-Ah Kim), 

Coming soon, part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake.

To learn more about the approval of Cimerli, 

To learn more about ophthalmology biosimilars, 

To learn more about clinical efficacy testing, 

To learn more about our LinkedIn Live event on ophthalmology biosimilars, you can 

To check out the FDA’s overview page on biosimilars, 

To check out the FDA’s patient-focused biosimilar education materials (English and Spanish versions), 

To check out the FDA’s biosimilar education materials for health care professionals, 

For more information on the FDA's biosimilar curriculum, 

For more information on the FDA's free CE courses on biosimilars, 

 and use the filter function to select biosimilars.

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy

Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars

BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable

Biden Authorizes Update to the Biosimilar User Fee Act Through 2027

New Bill Aims to Remove Barriers to Interchangeable Biosimilars

Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years

It’ll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake

Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency

Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy

Biosimilars Policy Roundup for October 2022—Podcast Edition

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.

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

Patients in British Columbia, Canada, now have access to 3 new biosimilars for the prevention of blood clot disorders, all of which reference Lovenox (enoxaparin).

Redesca, Noromby, and Inclunox have been added to the list of reimburseable biosimilars covered by PharmaCare, the province’s public health plan. Noromby was developed by Juno Pharmaceuticals, Inclunox is a Sandoz product, and Redesca was developed by Valero Pharmaceuticals. Both the original and high-potency versions of the drugs are available for public reimbursement.

“We are very pleased to have secured public coverage for Redesca in British Columbia while its originator enoxaparin has been simultaneously delisted. Our biosimilar is now covered in every province, and it is already our best-selling drug. We anticipate further upside going forward now that it is publicly fully covered and that hospitals across the country are making the step to move to biosimilars LMWH [low molecular weight heparin]," said Frederic Fasano, president and chief operating officer at Valero, in a company 

Enoxaparin is a LMWH that acts as an anticoagulant medication for the treatment and prevention of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism both during pregnancy and following certain types of surgery. It is also used in patients with acute coronary syndrome and history of heart attacks and can serve as a replacement to oral blood thinners when other treatments for noncancer-related VTE have failed.

British Columbia is 1 of the 5 provinces and 6 jurisdictions that have a biosimilars 

 that enables reference products to be automatically substituted with a biosimilar version. British Columbia 

 its policy in November 2019, and in August 2020, it moved into the 

 of the program, which included the addition of 3 rituximab biosimilars to its list of options for patients to switch to from Rituxan.

 on November 30, 2021, which involves switching patients with type 1 or type 2 diabetes who are on or are scheduled to start therapy with the originator insulin lispro (Humalog) and insulin aspart (NovoRapid). By May 29, 2022, all patients will either have to switch or start therapy with biosimilars Admelog (insulin lispro) or Trurapi (insulin aspart) or risk losing coverage.

“Our government’s biosimilars program continues to help people in British Columbia save money by accessing more treatment options that are less expensive than the originator drug and are just as effective….The new biosimilars we are announcing will be of great assistance to those who develop blood clots, which can be deadly,” said Adrian Dix, Minister of Health, in a 

British Columbia officials specified that because enoxaparin is used in patients for less than 6 months, patients who are currently administered the reference product will not have to switch to a biosimilar and will be able to continue with their Lovenox prescription until their treatment course is complete.

Therefore, only patients who need to start a new enoxaparin treatment course will be administered a biosimilar. Exceptions may be granted for patients whose providers conclude that they are medically unable to take the biosimilars and whose exceptional coverage requests are approved by PharmaCare’s Special Authority branch.

Additionally, PharmaCare is updating how it provides coverage for treatments associated with cancer-related thrombosis, allowing patients with cancer to access dalteparin, enoxaparin, and tinzaparin without needing to try blood thinner warfarin first.

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

Blood Clot Prevention Biosimilars Achieve Reimbursement in British Columbia

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

As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.

Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability

Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.

BioRationality—FDA’s Guidance on Promotional Labeling

Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.

Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars

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

Ha Kung Wong, JD 2

, brings a wealth of experience to the field of intellectual property law, specializing in patent and trade secret litigation. Beyond courtroom battles, his expertise extends to negotiating complex agreements for mergers, acquisitions, and collaborations across diverse industries, including pharmaceuticals, biologics, and cutting-edge fields like digital health and artificial intelligence. Wong's client roster boasts renowned names like Alkermes, Allergan, and the Bill & Melinda Gates Foundation.

 delved into Wong's insights in an interview on proposed patent law changes poised to significantly impact the biosimilars sector. These changes encompass limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs).

Do you foresee any potential shifts or reforms in patent law that could positively or negatively impact the biosimilars sector in the near future?

Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next 

 movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world. That being said, there are a few things I think that we might want to keep an eye on. I say "very few" only because we've seen a lot of things introduced and not a lot of follow through. There's a lot of good intentions out there, but there's not a lot of follow through. That being said, here it is.

First of all, Senators [Peter] Welch [D, Vermont], [Mike] Braun [R, Indiana], and [Amy] Klobuchar [D, Minnesota] introduced legislation in the Senate, and Representative [Jodey] Arrington [R, Texas] in the House on January 2024 that would limit the number of patents that could be asserted in a patent litigation. If this were to proceed, this may or may not have a practical effect because we've seen that most Bundled Payments for Care Improvement 

lawsuits that have been asserted are asserted on 10 or less patents. So, having an artificial limit may not make it any better. But it might. Who knows? It is certainly something to keep an eye on.

The Biosimilar Red Tape Elimination Act was introduced in July 2023 by Senators [Mike] Lee [R, Utah], [Ben Ray] Lujân [D, New Mexico], Braun, and [J.D.] Vance [R, Ohio]. That bill would eliminate the 2 separate designations of biosimilars and interchangables, which we know, exist in the US and we are the only country that does that. Every other country in the world only has 1 level of biosimilarity. It's possible if the interchangability requirement was removed, there could be greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, like we see with generic drugs. There may be increased confidence in biosimilars because they would be seen as perhaps closer to the reference product.

The problem is that when people hear there's a "biosimilar" but there's a higher level called "interchangable", their automatic reaction is, "Well that means biosimilars are garbage, why would I want that? I want an interchangeable. Oh, there's no interchangable? Then I don't want that product."

I think it will help with consumer confidence, patient confidence, and will help with health care provider confidence because a lot of doctors just don't know the difference. 

In June 2023, Senators [Thom] Tillis [R, North Carolina] and [Chris] Coons [D, Delaware] reintroduced the Patent Eligibility and Restoration Act of 2023 to reform patentability requirements under Section 101. There, the bill seeks to clarify which inventions are eligible for patenting in the US. If that bill were to be passed, it would overturn Supreme Court decisions in Mayo, Alice, and Myriad, which we've all been talking about for 10 years. It would be really interesting to see how that would impact the pharmaceutical and biologics industry in particular.

Finally, there's been this increased congressional scrutiny of pharmacy benefit managers or PBMs. Congress has launched various investigations into PBM practices and while this isn't directly related to patent law reform, it could have a significant impact on biosimilar uptake given the preferential formulary coverage of biosimilars and how that plays a big role in whether biosimilars are used and whether cost savings are realized or not.

I've been on record saying this for a long time now. PBMs are middlemen that don't need to really be there, but at the end of the day, they end up increasing the cost for patients and it would be interesting to see if all this congressional scrutiny will lead to better cost savings for patients.

Videos

Ha Kung Wong, JD, examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and heightened oversight of pharmacy benefit managers.



Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong

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

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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