A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre Filled Syringe (40 mg) Continuously and Subjects Undergoing Repeated Switches Between Humira® Pre Filled Syringe (40 mg) and Hulio Pre-filled Syringe (40 mg)

Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira.
This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product.
The study will also assess safety, efficacy and immunogenicity between these two groups.

开始日期2022-11-21

申办/合作机构

Biocon Biologics, Inc.

[+2]

JPRN-jRCT2071200057

/ Completed临床1期IIT

A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study

开始日期2017-07-08

申办/合作机构-

CTRI/2016/02/006625

/ Completed临床3期

A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and HumiraÂ® (adalimumab) in patients with active rheumatoid arthritis - BMO-2

开始日期2016-08-09

申办/合作机构

Biocon Research Ltd.

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项与阿达木单抗生物类似药 (Biocon) 相关的文献（医药）

2022-01-01·Journal of colloid and interface science2区 · 化学

Facile construction of novel organic–inorganic tetra (4-carboxyphenyl) porphyrin/Bi2MoO6 heterojunction for tetracycline degradation: Performance, degradation pathways, intermediate toxicity analysis and mechanism insight

2区 · 化学

Article

作者: Cai, Mingjie ; Zhang, Huiqiu ; Li, Shijie ; Yang, Fang ; Liu, Jianshe ; Liu, Yanping ; Wang, Chunchun

Developing durable photocatalysts with highly efficient antibiotics degradation is crucial for environment purification. Herein, tetra (4-carboxyphenyl) porphyrin (TCPP) was loaded onto the surface of Bi₂MoO₆ microspheres to gain hierarchical organic-inorganic TCPP/Bi₂MoO₆ (TCPP/BMO) heterojunctions via a facile impregnation strategy. The catalytic properties of these catalysts were comprehensively investigated through the photodegradation of tetracycline hydrochloride (TC) under visible light. Among all the TCPP/BMO heterojunctions, the highest photodegradation rate constant (0.0278 min^-1) was achieved with 0.25 wt% TCPP (TCPP/BMO-2), which was approximately 1.15 folds greater than that of pristine Bi₂MoO₆ and far superior to pure TCPP. The extremely high photocatalytic performance is attributed to the interfacial interaction between TCPP and Bi₂MoO₆, which favors the efficient separation of charge carriers and the enhancement of visible-light absorbance. TCPP/BMO-2 possesses high mineralization capability and good recycling performance. Photo-induced O₂^-, h⁺, and OH were mainly responsible for the degradation of TC. The degradation pathways of TC and toxicity of degradation intermediates were analyzed based on the intermediates detected by the high performance liquid chromatography-mass spectrometer (HPLC-MS) and the toxicity assessment by the quantitative structure-activity relationship (QSAR) prediction. A possible photocatalytic mechanism over TCPP/BMO is proposed. This work offers an insight in developing the porphyrin-based organic-inorganic heterojunctions for effectively remedying pharmaceutical wastewater.

2020-06-01·Pharmacology research & perspectives4区 · 医学

Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab

4区 · 医学

ArticleOA

作者: Muniz, Rafael ; Iwura, Takafumi ; Yamamoto, Katsuhiko ; Schreiber, Stefan

Abstract:

FKB327 was approved by the European Medicines Agency as a biosimilar to European‐authorized adalimumab (Humira®; AbbVie Inc). Adalimumab is a monoclonal antibody, binding and inhibiting tumor necrosis factor (TNF)‐α with use indicated for several immune‐mediated, chronic, and inflammatory disorders. The approval is based on high similarity in the physicochemical properties between FKB327 and adalimumab. The objective of this study is to assess the biological similarity, with regard to Fab‐ and Fc‐associated functions, and describe the relationship between physicochemical and biological characterization and functional activity. State‐of‐the‐art orthogonal techniques were implemented to assess the structure and function of FKB327. Peptide mapping with liquid chromatography and mass spectrometry, capillary electrophoresis–sodium dodecyl sulfate, ultraviolet circular dichroism, size‐exclusion high‐performance liquid chromatography (HPLC), and cation exchange HPLC were the techniques used to assess structure. Functional activity was assessed with enzyme‐linked immunosorbent assay, surface plasmon resonance, and cell‐based assays. The polypeptide sequence of FKB327 was identical to that of adalimumab. FKB327 also was demonstrated to have a similar secondary and tertiary structure to adalimumab. Posttranslational heterogeneities, along with size and charge variants, were not clinically meaningful. FKB327 binds to TNF‐α, FcγR, the neonatal Fc receptor, and C1q, and induces apoptosis, antibody‐dependent cellular cytotoxicity, and complement‐dependent cytotoxicity. The binding and activity of FKB327 were similar to that of adalimumab. FKB327 shares similar structure and activity with adalimumab. Based on characterization of physicochemical and biological properties, FKB327 is expected to have a similar safety, immunogenicity, and efficacy profile to adalimumab.

2019-12-01·Arthritis research & therapy2区 · 医学

FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension

2区 · 医学

ArticleOA

作者: Matsunaga, Nobuhito ; Vargas, Juan Ignacio ; Stanislavchuk, Mykola ; El Khouri, Elias Chalouhi ; Kellner, Herbert ; Baranova, Elena ; Alten, Rieke ; Glover, Josephine ; Greenwald, Maria ; Porawska, Wieslawa ; Dokoupilova, Eva ; Genovese, Mark C

Abstract:

Objective:

To compare the efficacy, serum drug concentrations, immunogenicity, and safety of FKB327 with the adalimumab reference product (RP) in combination with methotrexate in patients with moderate-to-severe, active rheumatoid arthritis (RA).

Methods:

Patients were randomized 1:1 in a double-blind study (NCT02260791), received 40 mg of FKB327 or RP by subcutaneous injection every other week for 24 weeks (Period I), then re-randomized 2:1, remaining on the same study drug or switching to the other up to week 54 in an open-label extension (Period II, NCT02405780). Efficacy was evaluated using American College of Rheumatology (ACR20) response rate difference at week 24 with equivalence margins of ± 13% and − 12% to + 15% using 95% and 90% confidence intervals (CIs), respectively. Efficacy, serum drug concentrations, immunogenicity, and safety were compared at week 54.

Results:

A total of 730 patients were randomized in Period I (n = 367 FKB327, n = 363 RP), and 645 transitioned to Period II (n = 216 FKB327–FKB327, n = 108 FKB327–RP, n = 108 RP–FKB327, n = 213 RP–RP). At week 24, ACR20 response rates were 74.1% with FKB327 versus 75.7% with RP. 95% and 90% CI of the response rate difference were − 7.9 to 4.7% and − 7.3 to 3.6%, respectively, meeting predefined equivalence margins. The ACR20 response rate remained over 70% of patients to week 54 with all treatment sequences. In Period I, mean trough serum drug concentrations were slightly higher for patients receiving FKB327 than those receiving RP. Mean concentrations were stable over time and reflected steady state in Period II. The proportions of patients with samples positive for neutralizing antidrug antibodies (ADAs) were comparable (57.7% with FKB327 vs. 55.5% with RP) at week 24, and no consistent difference in ADA were seen between continuous and switched treatments in Period II. Efficacy was slightly reduced in the small proportion of patients with high ADA titers in all treatment groups. No clinically significant differences were observed in the incidence of commonly reported treatment-emergent adverse events between the treatments across Periods I and II.

Conclusion:

FKB327 was equivalent to RP in clinical efficacy and demonstrated comparable safety and immunogenicity in patients with moderate-to-severe RA. No effect of switching between FKB327 and RP was observed.

Trial registration:

ClinicalTrials.gov, NCT02260791, Registered 29 July 2014.ClinicalTrials.gov, NCT02405780, Registered 17 July 2015.

项与阿达木单抗生物类似药 (Biocon) 相关的新闻（医药）

2025-02-07

·PipelineReview

Equillium Announces Positive Data from Phase 2 Study Evaluating Itolizumab in Patients with Moderate to Severe Ulcerative Colitis

Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo Itolizumab was generally well tolerated consistent with prior clinical experience LA JOLLA, CA, USA I February 06, 2025 I Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, and Biocon Limited (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceutical company, today announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC). The double-blinded, placebo- and active-controlled Phase 2 clinical study evaluated the safety and efficacy of itolizumab in biologic-naïve patients with moderate to severe active UC. A total of 90 patients were randomized 1:1:1 to receive itolizumab (fixed dose of 140 mg), placebo, or adalimumab (a global standard of care biologic treatment used as an active control) every two weeks for an initial 12-week treatment period. The primary endpoint of the study was clinical remission as defined by Total Mayo Score, and secondary endpoints included the proportion of participants who achieved clinical response and endoscopic remission (evaluated by central endoscopy). The study was co-sponsored by Equillium and Biocon Limited and conducted at multiple clinical trial sites in India. The design and conduct of the trial were a collaborative effort, with input from the gastroenterology community and leading global clinical and scientific experts in the field of inflammatory bowel disease (IBD). “The CD6-ALCAM pathway is elevated in gastrointestinal inflammation and is associated with severity of disease in both ulcerative colitis and Crohn’s patients. As such, we are delighted with the strength of data across the primary and secondary endpoints of this Phase 2 study in moderate to severe ulcerative colitis patients,” said Dr. Stephen Connelly, chief scientific officer at Equillium. “Itolizumab was well tolerated and achieved a clinical remission rate of 23 percent despite an imbalance of more severe patients in the itolizumab arm compared to the other arms of the study. While these positive results add to itolizumab’s critical mass of safety and efficacy data across different patient populations, we are particularly encouraged by this data in the context of our Phase 3 EQUATOR study in acute graft-versus-host disease, where lower gastrointestinal pathogenesis is a key driver of mortality, with topline data expected this quarter.” “Itolizumab demonstrated proof of concept with a meaningful effect size – comparable to biologic standard of care adalimumab – in this Phase 2 study in subjects with moderate to severe ulcerative colitis,” said Dr. Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry at the University of Western Ontario. “Itolizumab represents a novel selective immune modifying mechanism of action with great potential in a treatment paradigm needing differentiation and improved outcomes for patients.” Summary of Key Study Results Baseline demographics of the study included a median age of 39 years, relatively equal proportions of male and female subjects evenly distributed among study arms, and a mean weight of 58 kilograms. Baseline disease severity of the study was greater in the itolizumab arm, where 23% of patients were classified as severe (Total Mayo Score of 11) versus 0% in the placebo and adalimumab arms, and 66% had left-sided colitis versus 30% and 43% in the placebo and adalimumab arms, respectively. The primary endpoint of the study was clinical remission, defined as Total Mayo Score of ≤ 2 with no individual sub-score greater than 1 at Week 12. Secondary endpoints included the proportion of participants who achieved clinical response (per Total Mayo Score) and endoscopic remission (evaluated by central endoscopy) at Week 12 and Week 24. Additional data is expected to be presented at a future scientific conference during 2025. * One patient from the adalimumab arm had ‘endoscopic remission,’ but was recorded as ‘not in clinical remission’ at week 12 due to missing sub-score data About Itolizumab Itolizumab is a clinical-stage, first-in-class immune-modifying monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. The blockade of CD6 with itolizumab has demonstrated a reduction in T effector cell proliferation and downregulation of several important pathways that contribute to T effector cell development. The downregulation of these pathways is accompanied by decreased secretion of the pro-inflammatory T effector cytokines IFN-γ, TNF-α, IL-6 and IL-17. Additionally, inhibiting the binding of ALCAM to CD6 modulates lymphocyte trafficking and results in reduced T effector cell infiltration into inflamed tissues. About Biocon Limited Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on Twitter: @bioconlimited for company updates. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells that drive a number of immuno-inflammatory diseases. It is currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and has exhibited positive data from both a Phase 2 clinical study of patients with moderate to severe ulcerative colitis and a Phase 1b clinical study of patients with lupus/lupus nephritis. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited, who also provides commercial manufacturing for the product. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15, has exhibited positive results in both a Phase 2 proof-of-concept clinical study of patients with moderate to severe alopecia areata and a Phase 1/2 proof-of-concept clinical study of patients with cutaneous T cell lymphoma (CTCL). EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21 at pre-clinical stage. For more information, visit www.equilliumbio.com . SOURCE: Equillium

临床结果临床2期免疫疗法引进/卖出

2024-09-25

·PRNewswire

Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024

Switching between adalimumab and adalimumab-fkjp in Phase 3 study in patients with chronic plaque psoriasis supports interchangeability between adalimumab and adalimumab-fkjp Biosimilarity between Bmab 1200 and reference biologic-Ustekinumab in pivotal Phase 3 trial in patients with moderate to severe chronic plaque psoriasis AMSTERDAM and BENGALURU, India, Sept. 25, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "The extensive range of new data being presented at EADV this year underscores Biocon Biologics' commitment to a high-science portfolio of biosimilar medicines that meet the clinical needs of physicians and patients while providing important sustainability benefits to health systems. These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity without variation of clinical outputs in patients with chronic plaque psoriasis." Poster Title: Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis: a phase 3, double-blind, randomised, parallel-group study Authors: Sarika Deodhar, Subramanian Loganathan, Ramesh Ks, Gopi Ranganna, Shiyao Liu, Matthew A. Hummel Hummel, Stefan Daniluk, Anna Hanczewska, Kamelia Vekovska, Maria Zegadlo-Mylik, Grazyna Pulka, Elena Wolff-Holz Abstract ID: 3809 Poster ID: P3241 Date/Time: 9:00am EDT, September 25, 2024 This study evaluated the pharmacokinetics (PK), efficacy, safety, and immunogenicity in patients with moderate to severe chronic Plaque Psoriasis (PPs) receiving adalimumab continuously and those undergoing repeated switches between reference adalimumab and adalimumab-fkjp. The primary objective was to evaluate interchangeability of low-concentration adalimumab-fkjp (40 mg/0.8ml) and high-concentration adalimumab (40 mg/0.4ml) by comparing adalimumab steady-state PK between switching and non-switching arms. The overall number and proportion of patients with Psoriasis Area and Severity Index (PASI) responses and static Physicians Global Assessment (sPGA) success were highly similar between the two arms at week 28. Treatment-emergent Adverse Events were comparable between switching [54 subjects (29.8%)] and non-switching arms [66 subjects (34.2%)]. The overall number and proportion of patients with PASI responses and sPGA success were highly similar between the two arms at week 28. This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of high-concentration reference adalimumab, and demonstrated PK equivalence between switching and non-switching arms. The overall data supports interchangeability between high-concentration adalimumab and low-concentration adalimumab-fkjp. This study was conducted to fulfill the U.S. Food and Drug Administration (FDA) requirement for designation as an "interchangeable" and has been submitted to the FDA. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "For physicians, an important unmet need is understanding the comparative safety, efficacy and exposure of an adalimumab biosimilar formulated at a low concentration and high-concentration adalimumab at dose parity. The data from the study shows clearly that in patients the same safety, efficacy and exposure when used at dose parity can be expected for both products. This in the context of multiple switches between the reference product and the biosimilar as required of an interchangeability study." Poster Title: A Randomized, Double-blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Reference Biologic-Ustekinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis 28-week Results Authors: Jacek Szepietowski, Adam Reich, Steven Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Junior Tsiskarishvili, Inese Kolontaja-Zaube, Airi Poder, Gursharan Singh, Subramanian Loganathan, Elena Wolff-Holz, Sarika Deodhar, Ashwani Marwah, Sandeep Athalye Abstract ID: 4382 Poster ID: P3266 Date/Time: 9:00am EDT, September 25, 2024 This pivotal Phase 3, randomized, double-blind, active controlled, parallel-group, multicenter study compared the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of Bmab 1200 with the reference product ustekinumab in adult patients with moderate to severe chronic plaque psoriasis (Pso). A total of 384 patients were evaluated for 52 weeks and the primary efficacy endpoint was percentage change from baseline (%CFB) in PASI at Week 12. In the primary efficacy analysis at 28 weeks, Bmab 1200 and ustekinumab were equivalent and the data support biosimilarity. The study established equivalent efficacy and comparable safety of Bmab 1200 with ustekinumab in patients with moderate to severe chronic plaque Pso. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "This pivotal trial of bUstekinumab clearly met the safety and efficacy endpoints, thereby fulfilling the expectations set for a biosimilar. bUstekinumab offers tangible promise for all patients qualifying for treatment with Ustekinumab." About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. SOURCE Biocon Biologics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果免疫疗法

2024-07-19

·Pharmaceutical Technology

Boehringer Ingelheim offers Humira biosimilar at 92% discount

Boehringer Ingelheim is a key player in the Humira biosimilars market. Image credit: Shutterstock / Tada Images. Boehringer Ingelheim will sell an unbranded version AbbVie’s reference drug at a 92% discount to gain traction in the Humira (adalimumab) biosimilar market. Patients will be able to purchase adalimumab-adbm exclusively through GoodRx, an online telemedicine company that works with pharma manufacturers to offer prescription drugs at reduced prices. Effective immediately, the price for a two-pack pre-filled syringe or autoinjector has been set at $550, representing a 92% discount on Humira’s list price, Boehringer Ingelheim and GoodRx said in a joint 18 July press release. AbbVie’s Humira lost patent protection last year, paving the way for a market proliferation of biosimilars. Biosimilars are drugs that are similar to US Food and Drug Administration-approved biologics. AbbVie’s anti-inflammatory blockbuster generated sales of $21.2bn in its last year of market exclusivity. Sales are expected to weaken, with an analysis by GlobalData predicting a revenue slump to $2.6bn by 2030. Humira previously cost $7,000 for a four-week supply at the list price. See Also: Exscientia acquires oral CDK7 inhibitor for $20m, plans breast cancer trial Gene therapy: How the CRO of Veristat cut trial database costs by 30% Humira’s weakening performance was captured when healthcare giant CVS Health dropped the medication from its list of covered drugs. CVS instead opted to launch a new subsidiary called Cordavis tasked with creating biosimilars. The company previously reported that the biosimilar market in the US is expected to top $100bn in revenues by 2029. Since Humira’s patents expired, 11 competitors have come to market with copycat drugs. Boehringer Ingelheim joined the arena last July with a branded version named Cyltezo – priced 5% lower than Humira. The company’s unbranded version, launched later, provided an 81% markdown on Humira. This price split strategy—launching branded and unbranded versions—was shared by Amgen and Biocon with their own Humira biosimilars Amjevita and Hulio. However, Boehringer Ingelheim had an underwhelming rollout with Cyltezo, with uptake slower than expected. The company even had to lay off employees earlier this year as a result. The GoodRx team-up is the latest effort by Boehringer Ingelheim to gain a share in the Humira biosimilar market. Boehringer Ingelheim’s value and access senior vice president Chris Marsh said: “Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease.” “Partnering with GoodRx to offer our biosimilar adalimumab-adbm at a low price to these patients helps us deliver on our commitment to lowering financial barriers and improving access to critical treatments.” AbbVie meanwhile has pinned hopes on its autoimmune drugs Skyrizi (risankizumab) and Rinvoq (upadacitinib) to counteract revenue losses from Humira. GlobalData analysts say that AbbVie’s two-pronged approach with these next-generation drugs means it has rebuffed much of its potential autoimmune sector marginalisation. For competitors on the other hand, it was a “missed opportunity”.

生物类似药上市批准基因疗法

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研发状态

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适应症	国家/地区	公司	日期
附着点炎相关关节炎	澳大利亚	Maxx Pharma Pty Ltd	2021-05-14
化脓性汗腺炎	澳大利亚	Maxx Pharma Pty Ltd	2021-05-14
多关节型幼年特发性关节炎	澳大利亚	Maxx Pharma Pty Ltd	2021-05-14
强直性脊柱炎	美国	Mylan Pharmaceuticals, Inc.	2020-07-06
银屑病关节炎	美国	Mylan Pharmaceuticals, Inc.	2020-07-06
溃疡性结肠炎	美国	Mylan Pharmaceuticals, Inc.	2020-07-06
克罗恩病	美国	Mylan Pharmaceuticals, Inc.	2020-07-06
类风湿关节炎	美国	Mylan Pharmaceuticals, Inc.	2020-07-06
幼年特发性关节炎	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05637515 (CTgov)	临床3期	斑块状银屑病	374	Humira (Group 1 :- Humira Continuously)	憲鬱廠繭夢鬱蓋積鑰觸(夢鏇餘憲積衊鏇淵艱繭) = 構淵醖範範選襯夢築艱獵夢醖製鏇廠獵鹽築願 (衊窪衊簾顧遞壓齋憲廠, 網糧壓簾鏇夢襯鹽廠鏇 ~ 製製膚積顧願製鑰鹹衊) 更多	-	2024-10-15
				Hulio+Humira (Group 2:- Repeated Switches Humira - Hulio)	憲鬱廠繭夢鬱蓋積鑰觸(夢鏇餘憲積衊鏇淵艱繭) = 獵糧鹽膚膚襯夢獵積鬱獵夢醖製鏇廠獵鹽築願 (衊窪衊簾顧遞壓齋憲廠, 廠鏇鹽獵獵選膚遞醖繭 ~ 簾壓壓餘範積範淵艱醖) 更多
UEGW2020	N/A	炎症性肠病	-	Adalimumab originator	廠糧憲醖艱憲窪鏇獵築(膚製積齋夢廠鏇鏇夢網) = 33% stopped the biosimilar medication due to an allergic reaction 窪鹹壓顧鑰鹹鹽製構鏇 (襯淵築鹹願憲襯繭艱鏇 ) 更多	-	2020-10-01
				Adalimumab biosimilar (Hulio)
NCT02260791 (Pubmed \| J Rheumatol \| Arthritis Res Ther) 人工标引	临床3期	类风湿关节炎	730	Methotrexate+Adalimumab-FKB-327	鑰憲範蓋顧蓋鬱觸艱鏇(鏇膚艱襯遞願壓餘鑰糧) = 構壓鑰艱網積鏇遞鏇鬱鏇齋蓋範製繭廠餘鑰艱 (壓獵網糧鑰鏇築鬱窪願 )	相似	2019-12-12
				Methotrexate+adalimumab	鑰憲範蓋顧蓋鬱觸艱鏇(鏇膚艱襯遞願壓餘鑰糧) = 鬱蓋簾衊襯蓋鹹築鹹製鏇齋蓋範製繭廠餘鑰艱 (壓獵網糧鑰鏇築鬱窪願 )
EULAR2019	临床3期	类风湿关节炎	728	FKB327	鑰網鹽鑰壓範艱壓餘鏇(鑰簾構艱蓋憲廠鹹廠網) = 壓鬱襯淵鏇窪築獵選積遞繭壓衊構廠襯顧膚製 (憲積鑰鹹襯築夢壓淵壓, 77.1 ~ 88.3) 更多	积极	2019-06-12
				Adalimumab RP	鑰網鹽鑰壓範艱壓餘鏇(鑰簾構艱蓋憲廠鹹廠網) = 顧觸範鑰壓膚餘鏇鑰鹹遞繭壓衊構廠襯顧膚製 (憲積鑰鹹襯築夢壓淵壓, 74.8 ~ 90.4) 更多
NCT02260791 (ARABESC \| FKB327-002, CTgov)	临床3期	类风湿关节炎	728	FKB327 (FKB327)	壓繭夢觸衊窪膚憲鏇選(製膚積構構遞膚鏇餘壓) = 鏇範觸醖獵構鹹構夢艱鑰鹹鏇膚醖鹽願齋廠憲 (遞憲壓壓鏇製繭襯觸艱, 簾鹽壓繭淵淵醖鏇憲壓 ~ 簾蓋選築顧選憲餘築餘) 更多	-	2017-09-20
				Humira® (Humira®)	壓繭夢觸衊窪膚憲鏇選(製膚積構構遞膚鏇餘壓) = 鏇製網蓋製製獵鑰積襯鑰鹹鏇膚醖鹽願齋廠憲 (遞憲壓壓鏇製繭襯觸艱, 範衊淵壓選構構淵觸範 ~ 積齋鏇襯衊膚憲網艱夢) 更多
NCT02260791 (FKB327-002, EULAR2017)	临床3期	类风湿关节炎 C-reactive protein \| antidrug antibodies	730	FKB327	醖憲築顧獵艱衊築襯網(鏇簾範醖顧醖遞積顧糧) = 艱願選鏇繭遞壓膚餘遞糧衊構淵衊獵襯夢獵窪 (觸膚衊淵獵淵繭鏇廠衊 )	积极	2017-06-14
				ADL	醖憲築顧獵艱衊築襯網(鏇簾範醖顧醖遞積顧糧) = 簾齋糧築積構膚糧構膚糧衊構淵衊獵襯夢獵窪 (觸膚衊淵獵淵繭鏇廠衊 )