Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)

The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.

Start Date18 Feb 2022

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03210259

/ CompletedPhase 3

VOLTAIRE-X: Pharmacokinetics, Safety, Immunogenicity and Efficacy of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: a Randomized, Double-blind, Parallel-arm, Multiple-dose, Active Comparator Trial

The primary objective of the trial is to assess the PK similarity between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®, in patients with moderate-to-severe chronic plaque psoriasis.
The secondary objectives of this trial are to descriptively compare the safety, immunogenicity and efficacy profiles between patients receiving Humira® continuously vs those who alternate between BI 695501 and Humira®.

Start Date10 Jul 2017

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT02871635

/ CompletedPhase 3

BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Primary Objective:
The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).
Secondary Objectives:
The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.

Start Date28 Sep 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Adalimumab-ADBM( Boehringer)

100 Translational Medicine associated with Adalimumab-ADBM( Boehringer)

100 Patents (Medical) associated with Adalimumab-ADBM( Boehringer)

Literatures (Medical) associated with Adalimumab-ADBM( Boehringer)

01 Aug 2025·Rheumatology and Therapy

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

Article

Author: Strand, Vibeke

This summary-of-research article presents the findings of a post hoc analysis comparing immunogenicity across the VOLTAIRE trials program, originally published in BMJ Open. Adalimumab-adbm (Cyltezo^®) is approved by the US Food and Drug Administration as an interchangeable biosimilar to the adalimumab reference product (RP; Humira^®). In this analysis of immunogenicity in patients who participated in VOLTAIRE-RA (NCT021372260), VOLTAIRE-CD (NCT02871635), and VOLTAIRE-PsO (NCT02850965), immune response was assessed in patients of each biosimilar and RP treatment arm at various time points, and further stratified by patient sex. Across VOLTAIRE trials, the incidence of immunogenicity parameters had similar trajectories and were highest in VOLTAIRE-PsO, followed by VOLTAIRE-CD and VOLTAIRE-RA, highlighting the effects of differences in patient populations and background medications on immune response for each indication. 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.

03 Apr 2025·EXPERT OPINION ON BIOLOGICAL THERAPY

A plain language summary of the pooled safety results of adalimumab-adbm from the VOLTAIRE clinical trials in people with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis

Article

Author: McCabe, Dottie ; Bender, Shaun ; Vinisko, Richard ; Shaberman, Amy ; Cohen, Stanley

Adalimumab, also known by the brand name Humira, is a drug that is approved for the treatment of many autoimmune conditions including rheumatoid arthritis, Crohn′s disease, and chronic plaque psoriasis.Adalimumab-adbm, known by the brand name Cyltezo, is a to Humira.While biologics are large, complex organic mols. made with living cells grown in culture, a biosimilar is a type of biol. that is highly similar to its , or original biol.The VOLTAIRE clin. trials compared adalimumab-adbm to the adalimumab reference product in people with rheumatoid arthritis, Crohn′s disease, and chronic plaque psoriasis.This summary reports the overall long-term safety results of the 5 VOLTAIRE clin. trials that were part of the program (called VOLTAIRE-RA, VOLTAIRE-RAext, VOLTAIRE-CD, VOLTAIRE-PsO, and VOLTAIRE-X).This is known as a .Overall, people who took part in the VOLTAIRE trials had very similar outcomes such as safety and drug effects when they switched from adalimumab reference product to adalimumab-adbm.The results of this study show that in people with rheumatoid arthritis, Crohn′s disease, or chronic plaque psoriasis who took adalimumab-adbm and adalimumab reference product, a similar number of people experienced side effects or had to stop taking the treatment.These results show that people who took adalimumab-adbm should have no more side effects than if they were to take the adalimumab reference product, and vice versa.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-text

02 Jan 2025·EXPERT OPINION ON BIOLOGICAL THERAPY

Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis

Article

Author: McCabe, Dottie ; Bender, Shaun ; Vinisko, Richard ; Shaberman, Amy ; Cohen, Stanley

OBJECTIVES:

This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn's disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP).

METHODS:

Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted.

RESULTS:

The mean length of follow-up was 62 weeks, 48 weeks, and 32 weeks for patients with RA, CD, and PsO, respectively. Rates of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) were similar among patients with RA and PsO, but slightly higher among those with CD. Incidence rates of all safety endpoints were consistent between the adalimumab-adbm and adalimumab RP treatment arms within each indication Subgroup analyses of patients with RA, CD, and PsO showed no between-group differences by age and sex.

CONCLUSIONS:

In patients with RA, CD, and PsO, there were no differences between biosimilar adalimumab-adbm or the adalimumab RP regarding the rate of AEs, SAEs, discontinuations due to AEs, deaths, or any AEs of special interest.

News (Medical) associated with Adalimumab-ADBM( Boehringer)

25 Aug 2025

·www.prnewswire.com

Crohn's Disease Market Projected to Grow at 4.3% CAGR (2020-2034), Driven by Improved Diagnosis, Pediatric Label Expansion, and New Second-line Therapies | DelveInsight

The Crohn's disease pipeline includes several drugs in mid- and late-stage development, poised for approval in the near future in both adults and pediatrics. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including RHB-104, Tulisokibart, LITFULO (ritlecitinib), AGMB-129, Duvakitug, and others. The expected launch of these therapies shall further create a positive impact on the Crohn's disease market. LAS VEGAS, Aug. 25, 2025 /PRNewswire/ -- DelveInsight's Crohn's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Crohn's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Crohn's Disease Market Report According to DelveInsight's analysis, the market size for Crohn's disease was found to be USD 10.8 billion in the 7MM, with roughly 8-10% of it being the pediatric market in 2024. The United States accounted for the highest market size of Crohn's disease, approximately 78% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Adalimumab (HUMIRA and its generics) accounted for the highest market share of ~ USD 4 billion in 2024 for the treatment of Crohn's disease in the 7MM. Based on DelveInsight's assessment in 2024, the 7MM had 2.1 million diagnosed prevalent cases of Crohn's disease, out of which almost 200,000 cases are pediatric. In 2024, it was estimated that almost 60% of the cases were within the moderate-to-severe category as compared to mild severity in the US. Leading Crohn's disease companies developing emerging therapies, such as RedHill Biopharma, Merck, Teva Pharmaceutical, Pfizer, Agomab Therapeutics, Sanofi, Medibiofarma, Eli Lilly, NImmune, Avobis Bio, Abivax, Roche, Telavant, Mesoblast, Takeda, AstraZeneca, and others, are developing novel Crohn's disease drugs that can be available in the Crohn's disease market in the coming years. The promising Crohn's disease therapies in the pipeline include RHB-104, Tulisokibart (MK-7240, PRA023), Duvakitug (TEV-574), LITFULO (Ritlecitinib/PF-06651600), AGMB-129, Balinatunfib (SAR441566), MBF-118, MORF-057, Omilancor (BT-11), AVB-114, Obefazimod (ABX464), Afimkibart (RVT-3101 or RG6631), RYONCIL (Remestemcel-L), Zasocitinib (TAK-279), AZD7798, and others. Discover what is the best medicine for Crohn's disease @ Crohn's Disease Medication List Crohn's Disease Market Dynamics Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as budesonide, although 5-Aminosalicylates (5-ASA) are considered when steroids are not suitable. For moderate disease, immunomodulators like azathioprine, methotrexate, and 6-mercaptopurine are commonly used. However, long-term steroid use is generally avoided due to potential side effects. Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. REMICADE, the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. HUMIRA, introduced in 2007, provided an alternative for patients not responding to traditional treatments or REMICADE. In 2008, CIMZIA became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment. In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. ENTYVIO, approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. STELARA, launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks. SKYRIZI, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. RINVOQ, a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance. OMVOH, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks. While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. ALOFISEL (darvadstrocel), an allogeneic stem cell therapy, was approved in the EU (2018) and Japan (2021) for complex perianal fistulas in Crohn's disease patients. However, despite initial promise, Takeda discontinued its marketing authorization in the EU (December 2024), withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned pediatric trial for refractory complex perianal fistulas from its pipeline, limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the ongoing challenges in developing and commercializing advanced regenerative therapies for Crohn's disease, particularly in niche indications. Regarding the challenges for biologics, the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including INFLECTRA, RENFLEXIS, AVSOLA, and others. In 2023, biosimilars for HUMIRA, including AMJEVITA and CYLTEZO, entered the market, further enhancing affordability. TYRUKO, the first biosimilar for TYSABRI, was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With STELARA experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now TREMFYA. TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist. In the pediatric segment, treatment-related challenges are even more pronounced due to limited approved options. HUMIRA and REMICADE remain the primary TNF inhibitors, but early disease onset, aggressive progression, and long-term immunosuppression risks create significant unmet needs. Recently, in April 2025, the European Commission approved STELARA for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, immunogenicity and secondary loss of response remain key concerns. To address these gaps, pharmaceutical companies are advancing novel mechanisms of action, including integrin blockers, IL-12/IL-23 inhibitors, and JAK inhibitors, aiming for improved efficacy, safety, and durability in pediatric patients. The anticipated approvals of ENTYVIO in the near future, followed by RINVOQ and OMVOH for pediatric Crohn's disease patients, will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response. The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with TNF inhibitors (HUMIRA, REMICADE), IL-12/23 inhibitors (STELARA), and IL-23 inhibitors (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as JAK inhibitors, immunomodulators, and first-in-class therapies like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with improved clinical profiles, subcutaneous formulations, and greater convenience, driving higher penetration in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation. Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in next-generation biologics, oral small molecules, and novel combinations, the Crohn's disease treatment landscape is set to evolve significantly, reshaping the standard of care for both adult and pediatric patients. To know more about FDA-approved drugs for Crohn's disease, visit @ Crohn's Disease Treatment Crohn's Disease Pipeline Therapies and Key Companies The promising late- and mid-stage emerging pipeline assets for Crohn's disease include RHB-104 (RedHill Biopharma), Tulisokibart (Merck), LITFULO (Pfizer), AGMB-129 (Agomab Therapeutics), Duvakitug (Teva Pharmaceuticals and Sanofi), and others. RHB-104, developed by RedHill Biopharma, is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing RHB-204, a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104). Tulisokibart is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023, Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease. AGMB-129 is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024, the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025, Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The other therapies in the pipeline for Crohn's disease treatment include Omilancor (BT-11): NImmune AVB-114: Avobis Bio/Alimentiv Obefazimod (ABX464): Abivax RVT-3101 (RG6631): Roche RYONCIL (Remestemcel-L): Mesoblast Zasocitinib (TAK-279): Takeda AZD7798: AstraZeneca Balinatunfib (SAR441566): Sanofi MBF-118: Medibiofarma MORF-057: Eli Lilly/Morphic Therapeutic And others As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a significant portion of Crohn's disease patients remains refractory to multiple therapies, underscoring the need for breakthrough innovations beyond current biologic and small-molecule options; however, biological therapies remain expensive and face accessibility challenges, JAK inhibitors like RINVOQ are limited by serious safety concerns, and brand erosion following the patent expiry of market leaders such as REMICADE, HUMIRA, ENTYVIO, and STELARA is expected to lead to sales decline. Moreover, Crohn's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Crohn's disease market growth. Discover more about Crohn's disease drugs in development @ Crohn's Disease Clinical Trials Recent Developments in the Crohn's Disease Market In July 2025, the Phase III trial evaluating VELSIPITY (Etrasimod) a product of Arena (a wholly owned subsidiary of Pfizer), for the treatment of adult participants with moderately to severely active Crohn's disease, was terminated due to lack of efficacy in sub-study 1. In June 2025, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn's disease. In March 2025, the FDA approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease. In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers. In February 2025, Eli Lilly and Company announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderate-to-severely active Crohn's disease receiving 2 years of continuous treatment with OMVOH achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure at the Crohn's and Colitis Congress (CCC). In January 2025, the FDA approved OMVOH (mirikizumab) for Crohn's disease, further solidifying the IL-23 inhibitor class. With strong long-term efficacy, OMVOH is also being investigated for pediatric patients, potentially addressing a significant unmet need in this population. Crohn's Disease Overview Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities. Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected. Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections. Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning. Crohn's Disease Epidemiology Segmentation The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Crohn's Disease Prevalence Age-specific Diagnosed Crohn's Disease Prevalence Severity-specific Diagnosed Crohn's Disease Prevalence Scope of the Crohn's Disease Market Report Therapeutic Assessment: Crohn's Disease current marketed and emerging therapies Crohn's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Crohn's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Crohn's Disease Market Access and Reimbursement Download the report to understand which factors are driving Crohn's disease market trends @ Crohn's Disease Market Forecast Table of Contents Related Reports Inflammatory Bowel Disease Market Inflammatory Bowel Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IBD companies including Takeda Pharmaceutical, Janssen Pharmaceuticals, Hoffmann-La Roche, Genentech, AbbVie, Boehringer Ingelheim, Gilead Sciences, Arena Pharmaceuticals, Eli Lilly, AstraZeneca, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ulcerative colitis companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including TiumBio Co., Jiangsu Gensciences Inc., Pfizer, Novo Nordisk, Genzyme, AbbVie, Bayer, Spark Therapeutics, G & P Bioscience, Gritgen Therapeutics, Biocad, Belief Biomed, Chugai Pharmaceutical, Staidson Beijing BioPharmaceuticals, Jiangsu Gensciences, Poseida Therapeutics, Chia Tai Tianqing Pharmaceutical Group, Takeda, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalPhase 2Orphan Drug

18 Nov 2024

·www.fiercepharma.com

Cleanup for the IL-23 class in ulcerative colitis as new drugs 'rapidly gained significant momentum': report

Spherix Global Insights notes that differentiation among the IL-23 therapies “will be essential” as Tremfya and Omvoh look to battle class front-runner Skyrizi. The new ulcerative colitis (UC) triumvirate in Johnson & Johnson’s Tremfya, AbbVie’s Skyrizi and Eli Lilly’s Omvoh is rapidly growing into the established UC market as this IL-23 inhibitor class of drugs look to make its mark.That’s according to a new report out by consultants at Spherix Global Insights, who found the IL-23 class “has rapidly gained significant momentum, capturing one-tenth of the advanced systemic UC market over the course of 2024.”UC is a chronic, autoimmune bowel disease that causes ulcers and inflammation in the colon and rectum. While chronic, the disease can ebb and flow, with flare-ups often causing more severe symptoms, such as having to go to the toilet very frequently, alongside stomach and joint pain.It is typically diagnosed in younger adults and requires lifelong treatment. Older drugs for UC have included the once megablockbuster Humira. AbbVie’s off-patent TNF blocker is, however, now being succeeded by cheaper biosimilars, namely Boehringer Ingelheim’s Cyltezo in the U.S.More recent offerings include Bristol Myers Squibb’s Zeposia, an oral sphingosine 1-phosphate (S1P) receptor modulator approved in 2021, as well as AbbVie’s JAK inhibitor (and Skyrizi sister med) Rinvoq. Pfizer’s Zeposia rival Velsipity, also an S1P, and Takeda’s Entyvio, a TNF-alfa antagonist, are also in the space.There are many more biologics and other older meds such as steroids and immunomodulators used for the condition. Last year, however, a new class came into play in this already heavily catered-for market. Lilly became the first company to win FDA approval for an IL-23 inhibitor in UC in 2023, followed by AbbVie’s Skyrizi and, most recently, J&J’s Tremfya, as each drug looks to build up growing autoimmune profiles.By talking to more than 100 doctors, Spherix found that Tremfya “has made a strong debut,” with a “large majority” of gastroenterologists aware of its September approval.The analysts found that one-fifth of gastroenterologists have already prescribed Tremfya, “surpassing early trial rates for Lilly’s Omvoh at a similar post-launch timeframe,” though they note this falls short of what they tracked for Skyrizi.In the coming six months, gastroenterologists told Spherix they project Tremfya’s growth to “outpace Omvoh,” positioning the J&J drug as the likely second most prescribed IL-23 therapy, behind Skyrizi, which has more understanding by doctors, having been on the market in other indications for many years.Spherix notes that differentiation among the IL-23 therapies “will be essential” as Tremfya and Omvoh look to battle Skyrizi.The firm points out each company is already tapping into this, with Omvoh standing out for its impact on bowel urgency, while Tremfya is noted for its dual mechanism that binds not only to IL-23 but also to CD64, a receptor on IL-23-producing cells. Skyrizi, meanwhile, looks to distinguish itself with an on-body injector device and its earlier approval for Crohn’s disease, “which gave physicians valuable experience with the drug before its approval for UC,” Spherix notes.

Drug ApprovalBiosimilar

26 Aug 2024

·www.fiercepharma.com

Cigna's Express Scripts to cross out AbbVie's Humira from some formularies in 2025, opts to go with biosims instead

Cigna's Express Scripts is following CVS Caremark in excluding branded Humira from its formularies. When CVS Caremark removed AbbVie’s Humira from its national commercial formularies back in April, biosimilar prescriptions picked up at a whirlwind pace. Now, Cigna’s Express Scripts is following suit in a move that could further chip away at Humira’s market share.Express Scripts, which is Cigna’s pharmacy benefit unit, is removing branded Humira from its largest commercial formularies come 2025 in favor of biosimilar options from Teva, Sandoz and Boehringer Ingelheim.“We’ve been thoughtful in developing a comprehensive approach that considers not just the formulary placement of biosimilars, but also each product’s clinical efficacy, interchangeability, available supply, dose, and concentration that will provide a seamless patient experience with these more affordable products,” Express Scripts President Adam Kautzner said in a release, adding that the company is “prepared to embrace the savings biosimilars offer."AbbVie did not immediately respond to Fierce Pharma’s request for comment. Express Scripts first added Boehringer Ingelheim’s Humira copycat Cyltezo and Sandoz’s Hyrimoz—plus Sandoz’s unbranded biosim—as preferred products to its National Preferred Formulary last July. The company’s parent group Evernorth, which is also owned by Cigna, previously estimated that biosimilar competition can save the U.S. up to $375 billion in total pharmacy spending over the decade.While the onslaught of biosimilar competition has led to a sizable decline in AbbVie’s Humira sales, the originator's remaining 82% market share shows that supplanting the entrenched product won't be easy for the biosimilar marketers. In September, a Spherix Global Insights analysis revealed that prescribers had not yet “wholly warmed to these newcomers,” with dermatologists in particular showing the “highest degree of stated resistance to change.” As it stands, Sandoz’s Hyrimoz has been responsible for “most biosimilar gains," scoring about four-fifths of Humira biosimilar prescriptions through April 25, a Samsung Bioepis report found. On the flip side, a rough launch for Boehringer Ingelheim’s Cyltezo prompted layoffs in its customer-facing Cyltezo teams in a pivot to a hybrid in-person and virtual sales model.Meanwhile, at AbbVie, the company’s strategy to weather the impact of the Humira sales erosion with successors Rinvoq and Skyrizi is panning out as planned. Its recent quarterly Humira sales plunge of 29.8% was once again balanced out by double-digit growth for the two newer drugs, with Skyrizi steadily creeping up on Humira's level of sales.

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Approved

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Indication	Country/Location	Organization	Date
Axial Spondyloarthritis	European Union	Boehringer Ingelheim International GmbH	10 Nov 2017
Axial Spondyloarthritis	Iceland	Boehringer Ingelheim International GmbH	10 Nov 2017
Axial Spondyloarthritis	Liechtenstein	Boehringer Ingelheim International GmbH	10 Nov 2017
Axial Spondyloarthritis	Norway	Boehringer Ingelheim International GmbH	10 Nov 2017
Hidradenitis Suppurativa	European Union	Boehringer Ingelheim International GmbH	10 Nov 2017
Hidradenitis Suppurativa	Iceland	Boehringer Ingelheim International GmbH	10 Nov 2017
Hidradenitis Suppurativa	Liechtenstein	Boehringer Ingelheim International GmbH	10 Nov 2017
Hidradenitis Suppurativa	Norway	Boehringer Ingelheim International GmbH	10 Nov 2017
Pediatric Crohn's Disease	European Union	Boehringer Ingelheim International GmbH	10 Nov 2017
Pediatric Crohn's Disease	Iceland	Boehringer Ingelheim International GmbH	10 Nov 2017
Pediatric Crohn's Disease	Liechtenstein	Boehringer Ingelheim International GmbH	10 Nov 2017
Pediatric Crohn's Disease	Norway	Boehringer Ingelheim International GmbH	10 Nov 2017
Psoriasis	European Union	Boehringer Ingelheim International GmbH	10 Nov 2017
Psoriasis	Iceland	Boehringer Ingelheim International GmbH	10 Nov 2017
Psoriasis	Liechtenstein	Boehringer Ingelheim International GmbH	10 Nov 2017
Psoriasis	Norway	Boehringer Ingelheim International GmbH	10 Nov 2017
Uveitis	European Union	Boehringer Ingelheim International GmbH	10 Nov 2017
Uveitis	Iceland	Boehringer Ingelheim International GmbH	10 Nov 2017
Uveitis	Liechtenstein	Boehringer Ingelheim International GmbH	10 Nov 2017
Uveitis	Norway	Boehringer Ingelheim International GmbH	10 Nov 2017

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic large plaque psoriasis	Phase 3	United States	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Czechia	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Estonia	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Germany	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Poland	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Russia	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Slovakia	Boehringer Ingelheim GmbH	17 Aug 2016
Chronic large plaque psoriasis	Phase 3	Ukraine	Boehringer Ingelheim GmbH	17 Aug 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05203289 (CTgov)	Phase 1	-	200	BI 695501 - higher concentration (BI 695501 40 mg/0.4 mL (T))	mzqfyalxxv(brsljfeuun) = ftkacsdsnh htyxqrpfim (ifbmnckyit, 37.600) View more	-	15 Mar 2024
				BI 695501 - lower concentration (BI 695501 40 mg/0.8 mL (R))	mzqfyalxxv(brsljfeuun) = yslqeiiaov htyxqrpfim (ifbmnckyit, 37.600) View more
FDA Manual	Not Applicable	Hidradenitis Suppurativa	326	Placebo	gvzjhqasnu(uilmoxkgxv) = vvuocehloi cqtumtiaog (mdlqiljlim ) Met	Positive	22 Mar 2023
				Adalimumab-ADBM 40 mg	gvzjhqasnu(uilmoxkgxv) = lgmrtwnske cqtumtiaog (mdlqiljlim ) Met
FDA Manual	Not Applicable	Hidradenitis Suppurativa	307	Placebo	tzlholxypq(yrqwyyuszx) = azszpwguvc tawgstezfo (qdwwqzgabb )	Positive	22 Feb 2023
				Adalimumab-ADBM 40 mg	tzlholxypq(yrqwyyuszx) = hstdoxyein tawgstezfo (qdwwqzgabb )
NCT03210259 (VOLTAIRE-X, Pubmed) Manual	Phase 3	Plaque psoriasis	238	BI 695501	fzskuehqwz(rofcrzyrzp) = nawmwczxlj bnhqkixqdk (pyoopxnzew ) View more	Positive	07 Aug 2022
				Adalimumab	fzskuehqwz(rofcrzyrzp) = nucerjemzg bnhqkixqdk (pyoopxnzew ) View more
DDW2022	Not Applicable	Crohn Disease	-	Infliximab	zhxauwqmet(tfjbnapdgp) = no significant differences were observed between placebo, comparators or any biologic hkatavkpqp (lwbxwuwnwo ) View more	-	22 May 2022
				Adalimumab
NCT02871635 (VOLTAIRE-CD, Pubmed) Manual	Phase 3	Crohn Disease	147	BI 695501	cuoequxgtb(kmpkbnuuwz) = jcaylahabv cffcpnoshl (kilqkllzpv )	Similar	01 Oct 2021
				adalimumab+adalimumab	cuoequxgtb(kmpkbnuuwz) = tsfxeluujf cffcpnoshl (kilqkllzpv )
NCT03210259 (VOLTAIRE-X, CTgov)	Phase 3	Plaque psoriasis	259	Humira+adalimumab (Switching Arm (Post-Randomization Period))	vieveftzto(staybqleyf) = kagruinchw zmyppuczxy (qqevhejiqj, 1420) View more	-	02 Jul 2021
				Humira (Continuous Humira (Post-Randomization Period))	vieveftzto(staybqleyf) = ketrvxnsqv zmyppuczxy (qqevhejiqj, 1600) View more
NCT02850965 (VOLTAIRE-PSO, Pubmed \| Expert Opin Biol Ther) Manual	Phase 3	Chronic large plaque psoriasis	317	BI 695501	uzzjuyqjzc(fibadrubhn) = fftezhcycd bntbrpzrgj (lbqtnzyigd ) View more	Similar	01 Jan 2021
				adalimumab	uzzjuyqjzc(fibadrubhn) = vebdvrtnby bntbrpzrgj (lbqtnzyigd ) View more
UEGW2020	Not Applicable	Crohn Disease	-	BI 695501	xvzzvbczdl(avdubsrupm) = Defined as drug-induced liver injury, anaphylactic reactions, serious infection and hypersensitivity reactions xblzvizhnj (cqxczaowhu ) View more	-	01 Oct 2020
				Adalimumab RP
NCT02871635 (VOLTAIRE-CD, CTgov)	Phase 3	Crohn Disease	147	BI 695501	hmlqxjmzim = fuqxkrqtwl okwemeueet (dflopkqsuo, zjhbpupvqw - crwwcrrlrc) View more	-	04 Jun 2020

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