Adalimumab biosimilar Oct 29, 2024 · Humira, a medication for various autoimmune conditions, now has biosimilar alternatives available, offering patients more choices in their treatment journey. today Nov 13, 2025 · Is there a list of all biosimilars approved in the United States? There have been 77 biosimilars approved by the U. Adalimumab is the best-selling drug in history, with more than $200 billion in global sales since its 2002 approval. , May 13, 2024 – Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to Humira® (adalimumab), in the U. Over the July 4 holiday weekend, seven Humira (adalimumab) biosimilars were launched, with various formulations and pricing options. 8 mL strengths, as interchangeable for all indications for adalimumab (Humira; AbbVie) that are not covered by orphan drug exclusivity, according to a press release. July Jul 31, 2023 · Comparison of Adalimumab Biosimilars *Based on publicly available information Aug 22, 2023 · Seven Humira biosimilars became available in July with promises of giving patients more low-cost adalimumab options. Since first launching in the U. Therefore, we aimed to verify the ability of ABP501 and SB5 to maintain the clinical and biochemical response induced by the Oct 11, 2024 · Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira. Beginning Jan. May 27, 2025 · Organon group of companies. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. market for all of 2023. Yes, with two exceptions. The original biological medicine was known by the brand name Humira. Upon the October 2018 release of four adalimumab biosimilars into the European market, those CYLTEZO® is a FDA-approved biosimilar to Humira®. Nov 18, 2019 · Pfizer Inc. 1 This milestone event ushered in a wave of competition, with nine FDA-approved biosimilars vying for market share and more to come. Reimaging what is possible with our integrated solutions In April 2024 alone, the adoption of the adalimumab biosimilar by CVS Caremark® clients and their members outpaced the adoption of adalimumab biosimilars across the entire U. 4 mL strength May 22, 2025 · The FDA has expanded the interchangeable designation for Yuflyma (adalimumab-aaty), a biosimilar to Humira, to include all presentations. 4mL strength. [43][44][45] It is administered by subcutaneous injection May 2, 2024 · CVS Caremark changed its formulary to favor Hyrimoz. Most biosimilars are based on this formula but without citrate. Of the larger PBMs, only Optum Rx so far has weighed in on a coverage decision. In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and Jun 9, 2025 · On January 1, 2025, IBX changed its preferred drug strategy for Humira and its biosimilars. This highlights the power of Caremark, CVS Specialty® and Cordavis working together to improve access to critical drugs and lowering Oct 19, 2023 · The patent expiry of Humira® in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita®, Amsparity®, Hulio®, Hukyndra®, Hyrimoz®, Idacio®, Imraldi® and Yuflyma® – for the treatment of various immune Plain language summary What is this article about? This article explored the characteristics of various adalimumab The World Health Organization (WHO) has defined a biosimilar as a drug that is similar in terms of quality, safety and efficacy (effectiveness) to the original licensed product. With the introduction of several Humira biosimilars, learn how ClearScript has been monitoring the landscape and adapting strategies to provide members access to cost-effective therapy options for better health. But this may not be what policymakers had in mind ten years ago when they first thought about biosimilar competition. Jul 21, 2023 · In recent years, the evolving landscape of biosimilars has contributed to an overwhelming amount of information flooding the market. Transition your appropriate patients to AMJEVITA®, a HUMIRA® (adalimumab) biosimilar with similar clinical benefit and familiar dosing. Methods The cohort consisted of patients treated with adalimumab at the Clinical Immunology Outpatient Department of the Erasmus Jan 30, 2024 · The launch of the first biosimilar of Humira (adalimumab) last year was a major opportunity to increase patient access to, and lower the costs of, one of the bestselling drugs in the U. Jul 26, 2016 · Adalimumab was the first fully humanized monoclonal antibody approved by the US Food and Drug Administration (FDA). Aug 26, 2024 · When CVS Caremark removed AbbVie’s Humira from its national commercial formularies back in April, biosimilar prescriptions picked up at a whirlwind pace. You are receiving this leaflet because NHS England is recommending a biosimilar switch across the UK with the aim of making the most of NHS resources. Information updated in February 2021 from guidance originally written to help with the switching process from Humira (adalimumab) to adalimumab biosimilars in England in 2019. But there are still several A number of biosimilars of adalimumab, infliximab, etanercept, and rituximab RPs have been approved in the United States and/or European Union. Ridgefield, Conn. Organon. Makers of adalimumab biosimilars are offering deep discounts and using dual-pricing strategies to increase utilization. Food and Drug Administration (FDA). U. 1,2 In 2023—over 20 years after Humira’s launch—9 biosimilars were introduced, creating a disruption in the adalimumab market. S. As a first step to improve biosimilar adoption, we hope that our findings can inform dermatologists about potential savings associated with prescribing biosimilars. 2 Feb 20, 2024 · Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Most are also approved for hidradenitis suppurativa — a Nov 17, 2025 · Find out if there is a generic for Hyrimoz. In addition to the Humira reference product, there are currently 22 biosimilar versions of adalimumab in the U. in 2003, Humira® as a product has evolved in many ways including new concentrations, citrate free versions, latex free delivery devices, and smaller needle gauges. Nearly 88 percent of U. Apr 23, 2025 · Key Findings Biosimilar Adoption and Utilization The study demonstrated remarkably high rates of successful transition from Humira to biosimilar alternatives: 94% of members successfully switched to a biosimilar within three months of the formulary change 77% of patients initially transitioned to adalimumab-adaz (Hyrimoz equivalent) Nov 22, 2023 · Adalimumab (Humira, AbbVie) has become one of the world’s best-selling drugs for treating various inflammatory conditions spanning dermatology, gastroenterology, and rheumatology since its December 2002 US approval. market plus one “follow-on biologic” (Cordavis by AbbVie). Discover how biosimilars provide cost-effective treatment options for autoimmune diseases and compare Hyrimoz to other adalimumab biosimilars, including their key differences and availability. Adalimumab is indicated for the treatment of rheumatoid Sep 4, 2024 · The Humira biosimilar market just took another step forward—but remains far from its ideal state. But there are still several Understanding biosimilars CYLTEZO, or Adalimumab-adbm, is a biosimilar, a type of biologic that was created based off of Humira, the original biologic, or reference product and is just as safe and effective. Feb 26, 2025 · Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study. In this Adalimumab-adbm, our interchangeable biosimilar to Humira, now available at a low wholesale acquisition cost. Mar 18, 2025 · Biocon’s ustekinumab biosimilar matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting. However, despite competition from 14 lower-cost, FDA approved biosimilar versions, many commercial, employer and government payers and their PBMs have been slow to adopt these medications. “Boehringer Ingelheim is dedicated to broadening access to essential biologic medicines, and our collaboration Adalimumab Biosimilar Comparison Chart 1 20mg for pediatric use (citrate free), Humira 40mg/0. Mar 29, 2024 · Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years. Jul 3, 2023 · IDACIO® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira® (adalimumab). Dec 9, 2023 · A review article discussed the characteristics of the available adalimumab biosimilars to help clinicians navigate the various treatment options with their patients. 8mL vial discontinued 2 Pre-filled syringe available soon Read more about how the FDA have approved CYLTEZO as the first interchangeable biosimilar with Humira®, supported by data from BI’s Phase III clinical trial. Biosimilars for Humira use the adalimumab molecule that offers the same benefits and is designed to have the same mechanism of action that inhibits tumor necrosis factor (TNF) protein. Visit our site to find coverage details now. These medications join adalimumab-atto (Amjevita), the first adalimumab biosimilar that launched on Jun 23, 2025 · Switching from bio-originator Humira to a biosimilar peaked in April 2024 – the month an important formulary change took effect – and remains higher than 2023, suggesting growing adoption of biosimilars. Despite potential savings, payers and providers have been reticent to adopt biosimilar competitors. North Chicago, Illinois, US) is a fully human, recombinant, IgG1 monoclonal antibody 5 targeting TNF-α. This aligns with the availability of FDA-approved biosimilars that provide clinically equivalent outcomes at significantly reduced costs. 1 mL, 20 mg/0. 1, 2025, Optum Rx will prefer a different set of Humira biosimilar on its commercial The patent expiry of Humira ® in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita ®, Amsparity ®, Hulio ®, Hukyndra ®, Hyrimoz ®, Idacio ®, Imraldi ® and Yuflyma ® - for the treatment of various immune and inflammatory conditions. Last week, Cigna’s Express Scripts announced that it that will follow CVS Health’s CVS Caremark business and remove Humira from its largest commercial formulary in favor of multiple biosimilars. They join Amgen For years, Humira® (adalimumab) has been a significant driver of healthcare costs due to its high price and utilization. Apr 15, 2025 · YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, that is now interchangeable [1] Interchangeable designation of Aug 14, 2023 · Adalimumab — commonly known by its brand name, Humira — is getting more competition this year. This article is focused on the seven adalimumab biosimilars. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. Dec 6, 2021 · Currently, eight adalimumab biosimilars have received regulatory approval from the EMA and/or the US FDA. Integrating multiple orthogonal spectroscopic techniques provided robust evidence for structural similarity at both secondary and tertiary levels. Jun 28, 2023 · The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023. See full list on goodrx. Read more about how the FDA have approved CYLTEZO as the first interchangeable biosimilar with Humira®, supported by data from BI’s Phase III clinical trial. Jul 17, 2023 · July 2023 has seen a flurry of biosimilars being launched in the US, with various formulations and pricing options. 4 Adalimumab (Humira, AbbVie Inc. 10 Organon & Samsung Bioepis announce US launch of HUMIRA biosimilar HADLIMA™ (adalimumab-bwwd) in multiple presentations consistent with originator. As I noted last year, the large PBMs’ 2024 formularies generally supported the May 10, 2024 · The FDA has approved a supplemental biologics license application for Sandoz’s adalimumab-adaz (Hyrimoz), in the 10 mg/0. 1,2 Apr 15, 2024 · Are there biosimilar alternatives to Humira for RA treatment? Learn more here about the new Humira biosimilars released in the US throughout 2023. You are currently undergoing treatment with the biological medicine Adalimumab. Q5140 - adalimumab-fkjp Q5141 - YUFLYMA, adalimumab-aaty Q5142 - SIMLANDI, adalimumad-ryvk Q5143 - CYTEZLO, adalimumab-adbm Q5144 - IDACIO, adalimumab-aacf Q5145 - ABRILADA, adalimumab-afzb Change from Sep 26, 2024 · Adalimumab biosimilars will instead be the preferred products for this formulary. Below, we break down the new Humira biosimilars launching this month. Below, we review the 20 products competing with Humira—including four private-label products A biosimilar is a medication designed to work the same way as Humira (adalimumab) but may be more affordable. (NYSE: PFE) today announced the United States (U. The most recent biosimilar approval was Poherdy (pertuzumab-dpzb) on November 13, 2025. The citrate-free, injectable medication is used to treat or reduce the signs and symptoms of certain autoimmune conditions, such as rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and ulcerative colitis. 5 The CYLTEZO switching study was conducted in patients with plaque However, adalimumab is likely to present unique challenges given the numbers of patients treated and the range of biosimilar adalimumab products available. While still early in the launch of adalimumab biosimilars, this case study demonstrates that bio-similars are not always adopted despite having lower prices. There are additional biosimilars in development that will likely become available in the next few years. Furthermore, some adalimumab biosimilars have received FDA-approval for interchangeable designation. More than 1 in 8 patients who initiated a biosimilar switched back to bio-originator Humira; switching back was more common among older adults, women, and patients with rheumatoid YUSIMRY® (adalimumab-aqvh) is a multi-indication biosimilar* to HUMIRA® (adalimumab). All are approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s Disease and ulcerative colitis. These products include: Abrilada ® (adalimumab-afzb Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. Jan 21, 2025 · In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition. In the dermatology space, approvals of biosimilars for adalimumab, a tumor necrosis factor inhibitor used for the treatment of moderate to severe plaque psoriasis and hidradenitis suppurativa (HS), have been occurring since 2016; however, only recently has the Feb 24, 2024 · The FDA has approved Simlandi (adalimumab-ryvk), which joins Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as interchangeable with AbbVie’s Humira’s (adalimumab), the reference brand-name product that has set all kinds of sales records, for some uses. V. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. HYRIMOZ® is an adalimumab biosimilar manufactured by Sandoz Inc. The interchangeable designation applies to all approved indications of ABRILADA, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis Apr 3, 2025 · Co-production deals with adalimumab biosimilar manufacturers and PBMs have increased biosimilar adoption, but this consolidation of the drug supply chain could undercut competition. The arrival of these biosimilars Apr 6, 2024 · Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. Biosimilars are manufactured in FDA-licensed facilities. The Biosimilars Council is seeking to monitor adalimumab biosimilar performance and understand the key drivers behind biosimilar uptake. As anticipated, 2023 marked the end of exclusivity for Humira® (adalimumab), the world’s top-selling drug. See Important Safety Information including Boxed Warning, Prescribing Information, Medication Guide and Instructions for Use. On the next page is a list of biosimilars for adalimumab (Humira). Biosimilars that will be available include Cyltezo (adalimumab-adbm) and its unbranded version (Boehringer Ingelheim) in both high- and low-concentration formulations Simlandi (adalimumab-ryvk) (Teva), the first interchangeable biosimilar with Humira, high Feb 26, 2024 · Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product May 23, 2025 · YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and 80mg) INCHEON, South May 23, 2025 · YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and 80mg) INCHEON, South This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans. Hyrimoz is a biosimilar of Humira, and its generic name is adalimumab-adaz. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. Jun 9, 2025 · All four adalimumab biosimilars (ABP501, FKB327, MSB11022, and SB5) exhibited HOSs similar to the reference product Humira. May 28, 2024 · Originally, adalimumab formulations had lower concentrations and contained citrate, which can increase injection discomfort. Jun 3, 2025 · FDA grants interchangeability designation for Humira biosimilar to Samsung Bioepis, Organon Hadlima is now interchangeable with all presentations of Humira. Oct 18, 2021 · The U. Mar 15, 2025 · 10 biosimilars for adalimumab have been approved and marketed to date, and all share the same indications of the reference product. Now, Cigna’s Express Scripts is Jul 3, 2025 · Introduction Adalimumab is a monoclonal antibody that is used to treat autoimmune and inflammatory diseases. Oct 3, 2014 · Last update: 11 March 2024 Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. What is a Biosimilar? According the to FDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences Jun 9, 2025 · The FDA has expanded the interchangeable designation for Yuflyma (adalimumab-aaty), a biosimilar to Humira, to include all presentations. The products have list prices that range from 14% to 95% of Humira’s list price. Dec 17, 2024 · Boston— What effects do the introduction of biosimilars have on usage, pricing and spending for the original drugs? To help answer that question, a new study looked at adalimumab—marketed as Humira by AbbVie. Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. Cyltezo (adalimumab-adbm) is now approved as Mar 15, 2025 · 10 biosimilars for adalimumab have been approved and marketed to date, and all share the same indications of the reference product. YUSIMRY is indicated for use across multiple rheumatologic, gastroenterologic, and dermatologic indications, including: Jul 18, 2024 · Adalimumab-adbm is an FDA-approved interchangeable* biosimilar to Humira®. for a total of 10 adalimumab biosimilar products. A provisional determination was also provided for the 40 mg/0. This new biosimilar strategy provides continued quality of care for patients, guaranteed supply, availability of high-concentration doses, and affordability for patients, including manufacturer copay assistance programs and significant cost reduction for plan Apr 5, 2025 · The early adoption of adalimumab biosimilars in the US health care landscape presents key considerations for managed care stakeholders evaluating coverage decisions, patient access, and long-term cost management strategies. A high Biosimilars were created to reduce the financial expense of originators, thus allowing wider application of biologic treatment. The FDA has approved 10 Humira biosimilars, all proven to be just as safe and effective. Jul 30, 2025 · Patients with rheumatoid and psoriatic arthritis maintained stable disease activity and functional capacity, with even some improvement in ultrasound findings, after switching from original adalimumab to its biosimilar, GP2017. Jun 29, 2023 · The wait for adalimumab biosimilars has been long due to successful patent litigation, but 7 years after the first was approved, the wave of competitors for the reference product Humira, is Feb 20, 2025 · When it comes to how the three dominant PBMs treat Humira and its biosimilars, one year has made a big difference. Jul 5, 2023 · Most of the Humira biosimilars are available with two pricing options. Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira, is now commercially available in the U. Its first “biosimilar” came on the market at the end of January and at least eight more are expected in 2023. com 3 days ago · New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced treatment effectiveness and stability. Humira® (adalimumab) by AbbVie has been the top-selling biologic drug product for the last few years – reaching nearly $20 billion in annual sales in 2018. The biosimilar approval pathway has an emphasis on the pre-clinical analytic data in combination with clinical studies conducted to confirm therapeutic equivalence. Humira and all other Humira biosimilars became non-preferred. Infliximab Biosimilar Infliximab, brand name Remicade®, currently has three biosimilars on the market in the United States: Inflectra®, Renflexis®, and Introduction The first adalimumab biosimilar (Amjevita) was approved on September 23, 2016 and launched in the US market in January 2023. Dec 9, 2024 · Beginning in January 2025, Optum Rx will remove from several Humira biosimilars from its formulary, including Hyrimoz (adalimumab-adaz), the unbranded Hyrimoz and Cyltezo (adalimumab-adbm). Key Objectives After two decades on the US market, Humira began facing biosimilar competition in 2023. These highly anticipated biosimilars launched against the world’s top selling drug of all time 1. Apr 4, 2024 · There are ten FDA-approved biosimilars to Humira; nine launched in 2023. ) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira ® (adalimumab), 1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for Apr 15, 2025 · The FDA has accepted Yuflyma as an interchangeable biosimilar to adalimumab for the treatment of multiple chronic inflammatory diseases, Celltrion USA announced in a press release. Jul 4, 2025 · Real-world data show that patients switching from Humira to biosimilars Hadlima and Hyrimoz achieve similar outcomes without hospitalization. The market share of adalimumab biosimilars has increased from 2% in early 2024 to 22% by October 2024. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid Apr 30, 2024 · This is the first high-concentration, citrate-free biosimilar to Humira® granted an interchangeability status by the FDA and Alvotech will have interchangeable exclusivity for the 40mg/0. These products were approved under section 351(k) of the Public Health Service Act by demonstrating high similarity to the US reference product adalimumab (Humira) through comparative structural and physiochemical analyses, functional and biologica. Jun 16, 2025 · The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment. Amjevita, Hadlima ®, Hyrimoz and Yuflyma have recently become available in the USA, with Mar 24, 2023 · Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. 1-3 CYLTEZO also underwent a separate switching study to demonstrate interchangeability to Humira. 8mL vial discontinued 2 Pre-filled syringe available soon HYRIMOZ® is an adalimumab biosimilar manufactured by Sandoz Inc. This means that biosimilars (such as Yuflyma) are allowed to have small structural differences from the original licensed product (Humira) but this must not alter how well the drug works, how safe it is or how the drug Start your patients on CYLTEZO, the first ever FDA-approved Interchangeable biosimilar to Humira® 4 * Citrate-free CYLTEZO is the only adalimumab biosimilar with Phase 3 comparative clinical studies in three disease states. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. Jun 2, 2025 · In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four and Humira® interchangeables to six. Food and Drug Administration. Food and Drug Administration (FDA) has designated ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Mar 26, 2025 · AbbVie’s Humira was the top-selling drug in the world for many years. Jan 9, 2025 · Beginning in the spring of 2024, more insurers began to favor adalimumab biosimilar utilization, and an increase in biosimilar utilization has been seen with the removal of branded Humira from payer coverages. Jul 5, 2023 · Several biosimilar products to Humira ® (adalimumab), a tumor necrosis factor (TNF) blocker, have now been made commercially available. August 2022. Jul 1, 2025 · As part of our ongoing commitment to deliver cost-effective, quality care, we will replace Humira (adalimumab) and Stelara (ustekinumab) with biosimilar medicines, effective July 1, 2025. Since the FDA approval of the first adalimumab biosimilar there have been 9 other products approved, for a total of 10 adalimumab biosimilar products. Each of these biosimilars has been approved by the US Food and Drug Administration (FDA) based on thorough reviews of data showing their effectiveness and safety as compared to the original medication, Humira. In coordination with pharmaceutical manufacturer Fresenius Kabi, IBX included adalimumab-aacf (unbranded Idacio) as the only preferred biosimilar for Humira on the Select and Value Formularies. Interchangeability means the biosimilar can be substituted for the reference product or . market. The U. Apr 15, 2025 · YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, that is now interchangeable [1] Interchangeable designation of YUFLYMA® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis INCHEON, South Korea, April 14, 2025 -- Celltrion, Inc. (NYSE: PFE) today announced that the U. Infliximab and Adalimumab are the only two IBD biologic therapies that have FDA approved biosimilars on the market in the United States. Launched in 2003, the clinical efficacy and safety of adalimumab were assessed in Aug 26, 2024 · Beginning in 2025, Express Scripts will remove Humira (adalimumab) from its commercial formularies, favoring instead several biosimilars. prescriptions for adalimumab are for the high-concentration presentations [1]. Some of the branded (proprietary name) biosimilar products below may be available in an unbranded equivalent. 2 mL, and 80 mg/0. Sep 1, 2025 · Learn about SIMLANDI® | The first FDA-approved biosimilar interchangeable for the most widely prescribed formulation of Humira®: high concentration & citrate free. The Humira® biosimilars have arrived in the U. Now, its sales are eroding as doctors switch to biosimilars and new options enter the market. Apr 3, 2025 · Co-production deals with adalimumab biosimilar manufacturers and PBMs have increased biosimilar adoption, but this consolidation of the drug supply chain could undercut competition. Oct 21, 2025 · Adalimumab is used to treat plaque psoriasis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, and other chronic autoimmune conditions. Oct 5, 2023 · NEW YORK, October 5, 2023 – Pfizer Inc. We aimed to evaluate the effectiveness and adverse effects of Hyrimoz after Jun 11, 2025 · New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases. We aimed to evaluate the effectiveness and adverse effects of Hyrimoz after switching. Jul 17, 2023 · The list price of Humira (reference adalimumab) has risen so dramatically over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates. Learn about the differences between Humira and these biosimilar products. Since 2018, different adalimumab brands (also known as biosimilars) have become available. Note: Adalimumab is available in generic and biosimilar formulations. Newer Humira products are citrate-free and have higher concentrations, potentially making injections easier and faster. To date, data on effectiveness and safety of Adalimumab (ADA) biosimilars in inflammatory bowel diseases (IBDs) are lacking. Compare Humira and available biosimilars. See Safety Info, PI & Med Guide. US FDA approves additional formulation of Cyltezo® (adalimumab-adbm). Apr 15, 2025 · The FDA has designated yuflyma (Adalimumab-aaty; Celltrion, Inc) as an interchangeable biosimilar to adalimumab (Humira; AbbVie). Jan 22, 2025 · The Humira biosimilar market finally emerged in 2023. In January 2023, the first biosimilar version of adalimumab became May 7, 2025 · Nearly all Part D Prescription Drug Plans (PDPs) (96 percent), and 88 percent of Medicare Advantage Prescription Drug (MAPD) plans, covered at least 1 of the 10 available Humira biosimilars on their 2025 formulary—including some plans that covered Humira biosimilars only and not Humira. Preferred drugs added: Q 9996 Ustekinumab-ttwe SubQ Q 9997 Ustekinumab-ttwe I. Jun 6, 2024 · This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans. 6 days ago · Effective January 1, 2026, the Department will add preferred and non-preferred drugs to the Biosimilar PDL. Biosimilars for adalimumab, including Hyrimoz, have been developed. Food and Drug Administration today approved the first interchangeable biosimilar product to treat certain inflammatory diseases. The implications of this shift are profound, as it signifies a move toward increased patient accessibility and afordability for one of the costliest and Jul 5, 2023 · July 1 marked the launch of 5 different adalimumab (Humira) biosimilars, setting off the first round of therapeutic alternatives into the market, including adalimumab-abdm (Cyltezo), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), adalimumab-adaz (Hyrimoz), and adalimumab-fkjp (Hulio). These products were approved under section 351(k) of the Public Health Service Act by demonstrating high Discover how you can treat specific autoimmune and autoimflammatory conditions with HADLIMA™ (adalimumab-bwwd), an FDA-approved biosimilar of HUMIRA (adalimumab). Following recent EMA approval of the first high-concentration adalimumab biosimilar, CT-P17, this review provides a contemporary update on adalimumab biosimilars currently licensed in Europe and the USA. and indicated for the treatment of various inflammatory conditions. Dec 13, 2024 · In this cross-sectional study, we examined the use of and spending on Humira and 9 adalimumab biosimilars in the 4 quarters before and after the first biosimilar entered the US market in January 2023. 9 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license application 761059/S-005. Adalimumab biosimilar volume grew gradually through March 2024 with a crowded market led by Hadlima, a low-cost, high-concentration option from Organon The market for biosimilars was turned on its head in April 2024 as formularies shifted to cover Cordavis co-branded Hyrimoz and Humira rather than the branded reference product from AbbVie* Learn more about explaining biosimilars to your patients and HADLIMA™(adalimumab-bwwd), a HUMIRA (adalimumab) biosimilar with similar safety, purity, and potency. Given the numerous product attributes Adalimumab is a monoclonal antibody that is used to treat autoimmune and inflammatory diseases. Two recent retrospective studies, presented as posters at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025), provide important insights into these factors Biosimilars show comparable safety with Humira among new users with psoriasis in a multinational cohort study, but discontinuations were higher among those who switched from Humira to a biosimilar. The biosimilar was approved by the FDA in May 2023 as a high-concentration (100 mg/mL) and citrate-free formulation of adalimumab to treat various inflammatory conditions as a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. xrqa rpmj phukqf fhxug rrwwv spm pck qwrufrl iciuxckp srgkt pzfidq rvcd yfnv cczhhg ujebg