Cyltezo (adalimumab-adbm) / Boehringer Ingelheim - LARVOL DELTA

Assessing the Value of Biosimilars: A Cost-Effectiveness Approach for Managed Care Organizations. (PubMed, J Pharm Pract) - "Biologics included Humira, Remicade, and Lantus, with biosimilars Cyltezo, Avsola, and Semglee. Pharmacists can help lead biosimilar use through counseling and substitution protocols. Greater alignment between clinical evidence and formulary practices can lower costs, improve access, and promote sustainable care."

HEOR • Journal • Crohn's disease • Diabetes • Gastroenterology • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Type 1 Diabetes Mellitus

Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. (PubMed, Rheumatol Ther) - P3 | "Adalimumab-adbm (Cyltezo®) is approved by the US Food and Drug Administration as an interchangeable biosimilar to the adalimumab reference product (RP; Humira®). The same trend was observed in subgroup analyses by patient sex. These analyses show supporting evidence of the biosimilarity of adalimumab-adbm with adalimumab RP in adult patients with rheumatoid arthritis, Crohn's disease, and plaque psoriasis.Trial Registrations: VOLTAIRE-RA, NCT021372260; VOLTAIRE-CD, NCT02871635; VOLTAIRE-PsO, NCT02850965."

Journal • Retrospective data • Crohn's disease • Dermatology • Gastroenterology • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Rheumatology

Efficacy, Immunogenicity and Safety of Various Biosimilar Tumor Necrosis Factor Inhibitors in Ocular inflammatory diseases (ARVO 2025) - "Ten patients were on adalimumab biosimilars (6 Hyrimoz, 2 Hadlima, 1 Cyltezo, 1 Amjevita), and one was on infliximab biosimilar (Inflectra). Describe the big picture and the implications of your findings, not the study itself and the associated details. This study assesses the efficacy, immunogenicity and safety of tumor necrosis factor inhibitor biosimilars in ocular inflammatory disease, to evaluate their potential as a more affordable alternative to reference products and broaden access to biologics."

Clinical • Ocular Inflammation • Ophthalmology • Uveitis

Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. (PubMed, BMJ Open) - P3 | "Differences among the RCTs may partially be explained by concomitant background therapy (methotrexate) in the RA trial, stable doses of azathioprine, 6-mercaptopurine or methotrexate in 36% of patients with CD and absence of background therapy in the PsO RCT. The analyses further confirm the biosimilarity of adalimumab-adbm with the adalimumab RP across IMIDs and provide supporting evidence that adalimumab-adbm is an interchangeable biosimilar with consistent clinical results in patients originally treated with the RP."

Clinical • Journal • Retrospective data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Rheumatology

Acceptability of CYLTEZO pen among biologics autoinjector patients, autoinjector Naïve patients, and healthcare professionals. (PubMed, Expert Opin Drug Deliv) - "Nearly 90% of respondents indicated being 'very' or 'extremely' open to adopting the adalimumab-adbm pen. The adalimumab-adbm pen provided users with a positive experience with features that benefit perceptions of usability, handling, safety, convenience, and acceptability."

Journal

Summary of Research: Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA. (PubMed, Rheumatol Ther) - P3 | "The VOLTAIRE-RA trial compared the efficacy and safety of an adalimumab biosimilar (Cyltezo®, adalimumab-admb) with the adalimumab reference product, Humira®, in people with rheumatoid arthritis. A high proportion of people in this trial who were given adalimumab-adbm or adalimumab reference product reported greater improvement versus a reference US population matched by age and sex. This is notable, as it represents a treatment goal that was difficult to achieve in earlier rheumatoid arthritis trials of non-biologic treatments."

Journal • Patient reported outcomes • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for Adalimumab-adbm injection, Boehringer’s biosimilar to Humira (PRNewswire) - "Boehringer Ingelheim and GoodRx...announced today a patient affordability initiative to provide citrate-free Adalimumab-adbm, Boehringer's biosimilar to Humira (adalimumab), at a low cash price available exclusively on GoodRx...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....Beginning today, July 18, Boehringer and GoodRx are offering prices for both high-concentration and low-concentration citrate-free formulations of Adalimumab-adbm as a pre-filled syringe (10 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.8 mL or 40 mg/0.4 mL) or autoinjector (40 mg/0.8 mL or 40 mg/0.4 mL) at an exclusive cost of $550 per two-pack, which represents a 92% discount from the Humira list price."

Reimbursement • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

EFFICACY AND SAFETY OF ADVANCED MEDICAL TREATMENTS FOR INDUCTION OF REMISSION IN CROHN'S DISEASE: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS (DDW 2024) - "Combination of anti-tumor necrosis factor (TNF) and immunomodulators anti-TNF monotherapy (adalimumab [ADA] infliximab [IFX] BI695501) IL- 3 antagonists (ustekinumab [UST] guselkumab risankizumab [RIS] mirikizumab) anti-integrins (vedolizumab natalizumab) and upadacitinib were effective in inducing clinical remission compared to placebo (Figure 1). There was moderate certainty of evidence for combination of ADA and azathioprine (AZA) (RR 3...ConclusionOn network meta-analysis combination of anti-TNFs and immunomodulators followed by anti-TNF monotherapy had large effect size with moderate certainty for the induction of clinical remission. More novel therapies appear to have examples of similarly important effect sizes but are currently limited due to the imprecision of the limited evidence base at present and future research should target these therapies in study"

Metastases • Retrospective data • Review • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm phase I trial. (PubMed, Expert Opin Biol Ther) - P1 | "This study compared the relative bioavailability of citrate-free high-concentration and reference formulations of the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers. Overall, the high-concentration and reference adalimumab-adbm formulations had highly similar PK and immunogenicity profiles and were safe and well tolerated. NCT05203289."

Journal • P1 data

Boehringer Ingelheim expands access to adalimumab-adbm injection, the company’s biosimilar to Humira (Boehringer Ingelheim Press Release) - "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.S....Under the terms of the agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent. Boehringer Ingelheim will continue to commercialize Boehringer Ingelheim-labeled Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

US FDA approves high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira (PRNewswire) - "Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to treat multiple chronic inflammatory diseases....The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm."

BLA • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Immunomodulator and advanced therapies for Induction of clinical remission and response in Crohn’s disease: A systematic review and network meta-analysis (ECCO-IBD 2024) - "Combination of anti-tumor necrosis factor (TNF) and immunomodulators, anti-TNF monotherapy (adalimumab [ADA], infliximab [IFX], BI695501), IL-23 antagonists (ustekinumab [UST], guselkumab, risankizumab [RIS], mirikizumab), anti-integrins (vedolizumab, natalizumab) and upadacitinib were effective in inducing clinical remission compared to placebo (Figure 1). There was moderate certainty of evidence for combination of ADA and azathioprine (AZA) (RR 3.1, 95%CI [2.0-4.8]; risk difference [RD]: 40.1%), IFX+AZA (RR 2.5, 95%CI [1.7-3.8]; RD: 28.9%), ADA (RR 2.5, 95%CI [1.8-3.5]; RD:28.5%), and UST (RR 2.0 95%CI, [1.6-2.5]; RD: 19.2%) in induction of clinical remission compared to placebo...Conclusion On network meta-analysis, combination of anti-TNFs and immunomodulators followed by anti-TNF monotherapy had large effect size with moderate certainty for the induction of clinical remission. More novel therapies appear to have examples of similarly important effect sizes, but are..."

Immunomodulating • Metastases • Retrospective data • Review • Crohn's disease • Immunology • Inflammatory Bowel Disease • IL23A

Opportunities for Biosimilars: A Multidisciplinary Perspective: Episode 9 Defining Interchangeability and Switching in Biologics (Center for Biosimilars) - "This is a video synopsis/summary of a panel discussion involving esteemed experts...Alice B. Gottlieb, MD, PhD...Vibeke Strand, MD. The focus of this segment is on the crucial topic of interchangeability in biosimilars, shedding light on the FDA’s criteria and the implications for clinicians."

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Pooled Safety Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis (ACR Convergence 2023) - P3 | "In patients with RA, CD and PsO, there were no differences between biosimilar BI 695501 or the adalimumab RP regarding the rate of AEs, SAEs, discontinuations due to AEs, deaths, or the AESIs of serious infections, cancer, or MACE."

Clinical • Cardiovascular • Crohn's disease • Dermatology • Gastroenterology • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Myocardial Infarction • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology

Dr Stephen Hanauer Gives Insight Into Growing US Adalimumab Market (Center for Biosimilars) - "Stephen Hanauer, MD...comments on concerning data from Cardinal Health and Spherix Global Insights regarding the potential growth of the US adalimumab market, including providers' views on interchangeability and payers' influence on utilization."

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Summary of Research: Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. (PubMed, Dermatol Ther (Heidelb)) - P3 | "This Summary of Research overviews the results of the VOLTAIRE-X study (NCT03210259), which looked at what happened when people with plaque psoriasis continually took the adalimumab reference product (adalimumab RP; known by the brand name Humira) or switched three times between taking the adalimumab RP and BI 695501 (adalimumab-adbm, known by the brand name Cyltezo), an adalimumab biosimilar...There were no differences in effectiveness, side effects, or antibodies to adalimumab when comparing people who stayed continuously on adalimumab RP with those who switched between adalimumab RP and the adalimumab biosimilar adalimumab-adbm. On the basis of these results, adalimumab-adbm was approved by the US Food and Drug Administration (FDA) as interchangeable with adalimumab RP, meaning that a pharmacist can substitute the biosimilar adalimumab-adbm for adalimumab RP without requiring permission from the original prescriber (unless required to by state law)."

Journal • Dermatology • Immunology • Psoriasis

Dr Stephen Hanauer: Why More Studies Assessing Adalimumab Biosimilars in Gastro Conditions Are Needed - "Stephen Hanauer, MD...shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions."

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Dr Stephen Hanauer Welcomes Adalimumab Biosimilars to the Gastroenterology Space - "Stephen Hanauer...explained the initial experience gastroenterologists have had with anti-umor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space."

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Three biosimilars have now landed in our @SSMIBDCare New learning ✨ New experience ✨ Humira-adalimumab Amjevita- adalimumab-atto Cyltezo- adalimumab- adbm Yuflyma- adalimumab-aaty

Adalimumab-adbm, Boehringer Ingelheim’s Interchangeable biosimilar to Humira, now available at low wholesale acquisition cost (PRNewswire) - "Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company's interchangeable biosimilar to Humira® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-adbm is approved to treat multiple chronic inflammatory diseases and will be priced at an 81% discount to Humira. It is also available under the brand name Cyltezo®, which launched in July 2023 and is priced at a 5% discount to Humira."

Pricing • Ankylosing Spondylitis • Crohn's disease • Dermatology • Hidradenitis Suppurativa • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Adalimumab biosimilar BI 695501 (Cyltezo; adalimumab-adbm) in rheumatoid arthritis (YouTube) - "This video discusses the clinical equivalence of BI 695501 (Cyltezo; adalimumab-adbm) and adalimumab for rheumatoid arthritis - the VOLTAIRE-RA and extension studies."

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Interchangeable Biosimilars in Inflammatory Diseases (AJMC) - "Kay discussed the current landscape of adalimumab biosimilars, noting that 9 adalimumab biosimilars have been approved by the FDA as of June 19, 2023. He noted that the adalimumab biosimilars are characterized by different formulations, including low or high concentrations and citrate-free or citrate-containing buffers. Kay added that all the adalimumab biosimilars are accompanied by patient assistance programs, similar to those offered for the adalimumab reference product, and he explained that the adalimumab biosimilars faced delays in reaching the US market due to patent litigation with AbbVie. The biosimilar manufacturers reached agreements with AbbVie to pay royalties for intellectual property rights and have since been releasing their biosimilars to the market on prespecified dates in 2023."

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Biosimilars Stakeholder Summit: Interchangeable Biosimilars in Inflammatory Diseases : Episode 12 Patient and Provider Education on Biosimilars (AJMC) - "Jonathan Kay, MD: The infusible biosimilars doesn't need to be interchangeable because the infusion facility will infuse whichever biosimilars are on the formulary. And that decision is usually made based on costs. It's the self-administered biosimilars that are given this interchangeability designation. And as of now, the first self-administered biosimilar for inflammatory diseases is going to be adalimumab [Humira]. The first adalimumab biosimilar, currently as of June 19, 2023, the only one to have the interchangeable designation is Boehringer Ingelheim adalimumab biosimilar [Cyltezo]. But Pfizer just published the results of their interchangeability study, a successful study, that was conducted in rheumatoid arthritis patients in Lancet Rheumatology and the FDA is currently reviewing those data."."

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Eye on Pharma: Interchangeability Study Results; Express Scripts to Cover Cyltezo; TDM for Idacio (Center for Biosimilars) - "'For many health care professionals, therapeutic drug monitoring has become standard of care when treating inflammatory bowel disease patients with biologics and biosimilars. The availability of Anser testing for new agents, like these biosimilars, supports our mission as clinicians to get our patients expediently and cost-effectively into lasting remission,' said Adam Cheifetz, MD....'There is evidence on the clinical and health economic value of therapeutic drug monitoring for biologics and biosimilars in autoimmune diseases. The availability of Anser testing for an adalimumab biosimilar like Idacio will be a welcome addition to the care protocol of our Rheumatoid Arthritis patients,' commented Alan J. Kivitz, MD..."

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The ‘great American switching experiment’: Cyltezo debut ushers in interchangeable era (Healio) - "'My thoughts on interchangeability have been evolving over the last 7 or 8 years,' he said. Like many practitioners, Tesser was initially uncomfortable with the concept when it was first introduced. 'But I have been moving toward a different vantage point, recently, based on our experience with infliximab biosimilars,' he said. 'Recently, we have been able to choose one or another and have had experience with patients going back and forth with the reference biologic, and in most cases it does not appear to make a difference - with some nocebo exceptions. Why would it be different with adalimumab?' 'Non-medical switching is usually driven by insurance companies who aim to switch stable patients to less expensive medications, in the hope of lowering costs,' Gibofsky said. 'While Non-medical switching is undoubtedly a cost-motivated move from the insurance company, research suggests that it may not be an effective strategy for reducing costs.'"

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