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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

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Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.

Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market

Cameron Santoro is an associate editor for The Center for Biosimilars

Biosimilars offer a promising path to affordable, effective treatment, but barriers remain for underserved communities. This 2-part series explores the potential of biosimilars to improve health equity while addressing the obstacles that currently prevent access.

Part 1: Unlocking the Potential of Biosimilars to Improve Health Equity

Dive into biosimilar regulations in the US! Test your knowledge with our quiz on FDA rules, naming tricks, postmarket safety, and more. Ready for the challenge?

Quiz: The US Biosimilar Regulatory System

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

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

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Business & Practice

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

In late October 2023, the FDA approved Zymfentra (infliximab-dyyb), the world's first subcutaneous infliximab product. The product's development was based on Inflectra (infliximab-dyyb), an intravenous infliximab biosimilar referencing Remicade (infliximab). However, because the reference product does not have a subcutaneous option, Zymfentra was approved as a novel agent.

Zymfentra is also approved in Europe, where it's marketing under a different brand name. The product was developed by Celltrion, a Korean biopharmaceutical manufacturer that's shaping up to be a big player in the US biologics space. Zymfentra's subcutaneous presentation allows for easier and more convenient self-administration for patients, particularly those with inflammatory bowel disease (IBD), an umbrella term for ulcerative colitis and Crohn disease.

Zymfentra is also unique in that it was approved using data from 2 trials testing the product vs placebo in patients with ulcerative colitis and Crohn disease. Typically, infliximab biosimilars are tested in patients with RA or PsA and receive extrapolated indication for gastroenterology conditions. The LIBERTY trials offer gastroenterologists who may be wary of a subcutaneous infliximab option a degree of confidence that Zymfentra is safe and effective for patients currently on intravenous infliximab treatments.

We spoke with Andres Yarur, MD, a researcher on the LIBERTY trial and an associate professor of medicine at Cedars-Sinai Medical Center, to discuss the significance of his trial, the approval of a subcutaneous infliximab option, and what both mean for the future of IBD care.

To learn more about the FDA approval of Zymfentra, 

To learn more about the results from the LIBERTY trials, 

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur

On this episode, we will discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development

Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

Alvotech’s Stelara Biosimilar Approved in Japan

EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor

European Commission Approves First Aflibercept Biosimilar

Regulatory Updates From Around the Globe Provide Hope for Biosimilars

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Biosimilars Regulatory Roundup for September 2023—Podcast Edition

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 big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.

Rezvoglar Becomes Second Interchangeable Insulin Biosimilar

Biosimilar Business Recap: Progress for Insulin in Europe, Canada; Biocon Biologics' Viatris Acquisition Completed

The European Union Gains Another Ranibizumab Biosimilar

Alvotech Snags Australian Approval for Adalimumab Biosimilar

Biosimilar Check-in: PBM to Cover Adalimumab Biosimilars; World’s First Denosumab Biosimilar; Organon Launches in Canada

Senator Introduces Bill to Rid Switching Study Requirements for Interchangeability

BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program

AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?

Biosimilars Regulatory Roundup for November 2022—Podcast Edition

This episode is going to be recapping some of the biggest regulatory events to happen in the biosimilar space during the month of August, including 2 European approvals, 2 US approvals, including 1 for an interchangeable biosimilar, and the advancement of the Inflation Reduction Act of 2022.

Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics

https://www.centerforbiosimilars.com/view/opinion-impact-of-inflation-reduction-act-2022-addressing-critics

Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition

https://www.centerforbiosimilars.com/view/opinion-the-inflation-reduction-act-is-a-step-backward-for-biosimilar-competition

$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill

https://www.centerforbiosimilars.com/view/-35-insulin-cap-for-private-sector-blocked-from-budget-reconciliation-bill

European Commission Approves Second Lucentis Biosimilar

https://www.centerforbiosimilars.com/view/european-commission-approves-second-lucentis-biosimilar

FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab

https://www.centerforbiosimilars.com/view/fda-approves-coherus-cimerli-as-interchangeable-biosimilar-to-ranibizumab

FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar

https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-formulation-of-samsung-bioepis-humira-biosimilar

Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar

https://www.centerforbiosimilars.com/view/eye-on-pharma-celltrion-aims-for-adalimumab-interchangeability-phase-3-results-for-ustekinumab-biosimilar

EC Grants Celltrion Avastin Biosimilar Marketing Authorization

https://www.centerforbiosimilars.com/view/ec-grants-celltrion-avastin-biosimilar-marketing-authorization

BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar

https://www.centerforbiosimilars.com/view/bla-accepted-for-fresenius-kabi-tocilizumab-biosimilar

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

Biosimilars Regulatory Roundup for August 2022—Podcast Edition

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

 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

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

Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences?

We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, Zarxio, a filgrastim product developed by Sandoz. Paul helped explain these issues.

To hear more from Paul on biosimilar issues, click 

To read about Paul’s insight on the current issues in the Indian biosimilar market, click 

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert, explains the relevance of differences between biosimilars and reference biologics. 

Not So Different: Should Biosimilar Variations Be Concerning?

The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.

FDA Approves High-Concentration Cyltezo

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

Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

Julie Reed: Why 2024 Is Important for Biosimilars

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

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