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）

2024-01-01·Mymensingh medical journal : MMJ

A Systematic Review Evaluating the Efficacy, Immunogenicity and Safety of the Biosimilar FKB327 in Treating Rheumatoid Arthritis.

Review

作者: Islam, R ; Tanzeem, F

Biosimilars are known to be pharmaceutical products which are very similar to a biologic drug. FKB327 is one such biosimilar of the drug Adalimumab which is prescribed in treating autoimmune diseases like Rheumatoid Arthritis. The aim of this review is to evaluate the efficacy, immunogenicity and safety of the drug FKB327 in treating patients with mild to moderate Rheumatoid Arthritis and compare the same with that of the drug Adalimumab. Two databases (PubMed and Cochrane Library) were used to screen relevant publications using pre-determined inclusion and exclusion criteria. Of the 12 studies found to be relevant, 3 were found to be eligible for the review. The data were extracted for the study characteristics, outcome measures, complications, and safety. The quality of the papers was assessed through Jadad scoring. Three (3) papers were reviewed in the study although there were limitations in reviewing efficacy as one of the papers lacked required data for efficacy. Efficacy was observed through ACR20 response and DAS28 score in the 24th week of all the three studies and immunogenicity was reviewed through the presence of Anti-drug antibody in patients after administration of both the drugs in same dosage. Safety was assessed through the development of complications after the administration of the drugs. The review concludes that there are similarities in efficacy, immunogenicity and safety between FKB327 but could not adequately prove the superiority of FKB327 over Adalimumab.

2024-01-01·Therapeutic Advances in Gastroenterology

Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID

Article

作者: Abitbol, Vered ; Stefanescu, Carmen ; Peyrin-Biroulet, Laurent ; Fumery, Mathurin ; Buisson, Anthony ; Biron, Amélie ; Seksik, Philippe ; Altwegg, Romain ; Vuitton, Lucine ; Caron, Bénédicte ; Nahon, Stephane ; Bonnet, Joelle ; Wils, Pauline ; Laharie, David ; Moussata, Driffa ; Camara, Houda ; Guillo, Lucas ; Gilletta, Cyrielle ; Nancey, Stephane ; Savoye, Guillaume ; Bourreille, Arnaud

Background::

Several adalimumab preparations are now available for patients with inflammatory bowel disease (IBD). Comparative satisfaction and tolerability are unknown.

Objectives::

This study investigated IBD patient satisfaction with approved adalimumab biosimilars and their originator.

Design::

In this cross-sectional study, we included 941 consecutive adalimumab-treated patients with IBD across 45 centres affiliated with the Groupe d’Etude Therapeutique des Affections Inflammatoires du tube Digestif who completed a satisfaction questionnaire comprising four items each rated by a 10-point scale.

Methods::

The differences in responses were performed using a one-way analysis of variance followed by Tukey’s honest significant difference test.

Results::

The most commonly used drugs at inclusion were Humira® (436/941, 46.3%), Amgevita® (177/941, 18.8%) and Hulio® (105/941, 11.2%). The mean overall satisfaction rate with adalimumab was 8.5 (standard deviation 1.8). Overall satisfaction was significantly higher in patients treated with Humira (8.6 (1.5)), Hulio (8.6 (1.8)) or Amgevita (8.5 (1.4)) ( p < 0.05). Satisfaction with the subcutaneous injection form was higher for patients treated with Yuflyma® (9.0 (1.4)), Humira (8.9 (1.3)) and Hulio (8.9 (1.7)) ( p < 0.05). A total of 299 patients (31.8%) described injection site reactions. In all, 223 patients (23.7%) reported being previously treated with another adalimumab of which (32/223, 14.3%) discontinued treatment due to side effects.

Conclusion::

In this real-world setting, patients with IBD had a high level of satisfaction with adalimumab treatment, with some differences in terms of overall satisfaction and satisfaction with the injection device.

2023-11-01·Journal of comparative effectiveness research

Navigating adalimumab biosimilars: an expert opinion

Review

作者: Habauzit, Caroline ; Abitbol, Vered ; Benkhalifa, Salim ; Marotte, Hubert

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. Amjevita, Hadlima ® , Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). 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. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.

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

2024-12-17

·复宏汉霖

汉霖快讯 | 复宏汉霖加入Biosimilars Forum

近期，Biosimilars Forum（生物类似药论坛组织）宣布复宏汉霖成为其最新成员企业。Biosimilars Forum作为一个非营利组织，致力于推动生物类似药在美国的发展，扩大生物药物的可及性并改善医疗保健。复宏汉霖的首席商务官曹平女士表示：“复宏汉霖致力于与行业合作伙伴携手推进共同的使命，为全球患者提供高质量、可负担且高效的生物类似药。我们非常高兴能够在这一关键节点加入论坛。在当前阶段，提高这些药物的可及性和接受度对于降低医疗成本并改善患者健康状况至关重要。” Biosimilars Forum执行主任Juliana M. Reed女士表示：“我很高兴欢迎复宏汉霖成为生物类似药论坛的最新成员，我们的理事会和我都期待与复宏汉霖团队密切合作，共同致力于为患者提供低成本、安全且高效的生物类似药治疗选择。” 复宏汉霖是一家快速发展的生物制药企业，专注于开发、生产和销售优质的生物药，其产品已覆盖全球50多个国家，惠及患者超过70万人。迄今为止，复宏汉霖已自主开发并上市四款生物类似药，并全速推进10余款在研生物类似药的开发。其中，汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）是在中国、欧盟、美国获批的“中国籍”单抗生物类似药，现已成功于美国、英国、加拿大、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、泰国等国家和地区获批上市，并进入中国、英国、法国和德国等多个国家的医保目录。近期，公司亦完成汉曲优®首批美国商业化发货。复宏汉霖携手商业合作伙伴Accord、Abbott、Eurofarma、Organon和KGbio等国际一流的生物制药企业，前瞻性地开展了全球商业化布局。未来，复宏汉霖将继续深化与全球合作伙伴的协作，推进更多高品质药物的全球上市进程，惠及更多患者。关于Biosimilars Forum Biosimilars Forum致力于在美国推进生物类似药，旨在扩大生物药的可及性和可用性，从而改善医疗保健。该论坛通过提供基于证据的信息，支持和制定有助于提高生物类似药认知度、可及性和采纳率的公共政策。 Biosimilars Forum的成员包括大多数拥有重要美国生物类似药开发项目的企业，具体包括Amneal Pharmaceuticals、Biocon Biologics、复宏汉霖（Henlius）、Meitheal Pharmaceuticals、欧加隆（Organon）、辉瑞（Pfizer Inc.）、三星生物（Samsung Bioepis）、山德士（Sandoz）以及梯瓦制药（Teva Pharmaceuticals）。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Henlius Becomes Newest Member of Biosimilars Forum Recently, Henlius has been announced as the newest member company of the Biosimilars Forum, a coalition that advances biosimilars in United States with the intent of expanding access and availability of biological medicines and improving health care. "Henlius is committed to working with our industry partners to advance our mission of providing patients around the world with high-quality, affordable, and effective biosimilar medicines," said Ping Cao, CBO of Henlius. "We are so excited to join the Forum at this critical impasse — where access and adoption of these medicines is necessary to lower costs and improve healthcare outcomes for patients.” "I am excited to welcome Henlius as the latest member of the Biosimilars Forum," said Juliana M. Reed, Executive Director of the Biosimilars Forum. "Our Board of Directors and I look forward to collaborating with the Henlius team as we work to make biosimilars accessible to patients as lower-cost, safe, and effective options." Henlius is a rapidly growing biopharmaceutical provider that develops, manufactures, and distributes leading biologics in over 50 countries worldwide, serving more than 700,000 patients. To date, Henlius has independently developed and launched four biosimilars, in addition to more than 10 biosimilar candidates under development. Among them, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar that has been approved in China, the European Union (EU) and U.S. It is approved in the United States, United Kingdom, Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. Recently, HANQUYOU completed its first shipment to the United States. In collaboration with leading global biopharmaceutical companies such as Accord, Abbott, Eurofarma, Organon, and KGbio, Henlius has proactively established a global commercial layout for its biosimilar product portfolio. Looking ahead, Henlius will continue to strengthen its collaborations with global partners to accelerate the global launch of more high-quality medicines, benefiting more patients worldwide. About Biosimilars Forum The Biosimilars Forum works to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The Biosimilars Forum provides evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars. The members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios, specifically Amneal Pharmaceuticals, Biocon Biologics, Henlius, Meitheal Pharmaceuticals, Organon, Pfizer Inc., Samsung Bioepis, Sandoz, and Teva Pharmaceuticals. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

生物类似药上市批准

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

100 项与阿达木单抗生物类似药 (Biocon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
全葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
中间葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
后葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
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
强直性脊柱炎	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
银屑病关节炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
白塞氏葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
活动性中度克罗恩病	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
活动性重度克罗恩病	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
多关节型幼年特发性关节炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
脓疱型银屑病	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
类风湿关节炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
幼年特发性关节炎	欧盟	Biocon Biologics Ireland Ltd.	2018-09-17
幼年特发性关节炎	冰岛	Biocon Biologics Ireland Ltd.	2018-09-17
幼年特发性关节炎	列支敦士登	Biocon Biologics Ireland Ltd.	2018-09-17
幼年特发性关节炎	挪威	Biocon Biologics Ireland Ltd.	2018-09-17
小儿克罗恩病	欧盟	Biocon Biologics Ireland Ltd.	2018-09-17

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临床结果

适应症

分期

评价

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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)	膚鹹艱鏇夢願積築積齋(蓋窪膚齋構廠襯願積觸) = 衊夢築窪衊鏇簾觸範餘構網淵獵網淵獵遞製壓 (遞製醖糧廠築襯餘淵壓, 1432.80) 更多	-	2024-10-15
				Hulio+Humira (Group 2:- Repeated Switches Humira - Hulio)	膚鹹艱鏇夢願積築積齋(蓋窪膚齋構廠襯願積觸) = 糧齋鑰願淵選網鹹衊範構網淵獵網淵獵遞製壓 (遞製醖糧廠築襯餘淵壓, 1636.09) 更多
UEGW2020	N/A	炎症性肠病	-	Adalimumab originator	齋鹽鑰壓醖獵廠網積獵(繭構顧襯顧構觸選獵簾) = 33% stopped the biosimilar medication due to an allergic reaction 鬱簾蓋繭壓糧夢獵築鑰 (醖壓齋襯範膚積齋獵選 ) 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	選構淵積製鹹鹹鏇選壓(餘糧艱鬱窪糧廠製膚構) = 願製憲膚繭夢鹹遞蓋製網襯鬱夢繭獵網餘製築 (廠網襯蓋憲鬱繭憲製齋 )	相似	2019-12-12
				Methotrexate+adalimumab	選構淵積製鹹鹹鏇選壓(餘糧艱鬱窪糧廠製膚構) = 獵積衊鏇範糧顧築積製網襯鬱夢繭獵網餘製築 (廠網襯蓋憲鬱繭憲製齋 )
EULAR2019	临床3期	类风湿关节炎	728	FKB327	遞顧蓋鏇淵淵網獵選窪(鬱鹹廠廠觸製淵網醖鬱) = 簾淵積壓鹽餘夢襯構醖觸觸範餘壓餘憲鹽艱選 (鹽鏇觸蓋齋顧壓觸選鹹, 77.1 ~ 88.3) 更多	积极	2019-06-12
				Adalimumab RP	遞顧蓋鏇淵淵網獵選窪(鬱鹹廠廠觸製淵網醖鬱) = 餘構鏇齋鹽衊壓構蓋鏇觸觸範餘壓餘憲鹽艱選 (鹽鏇觸蓋齋顧壓觸選鹹, 74.8 ~ 90.4) 更多
NCT02260791 (ARABESC \| FKB327-002, CTgov)	临床3期	类风湿关节炎	728	FKB327 (FKB327)	襯蓋鹽顧簾廠齋願鹹糧 = 鬱鏇壓鏇網壓齋繭遞鹽淵築廠窪鹹蓋壓築網糧 (構鹹衊積鹽製壓遞襯獵, 觸鏇願簾醖願窪顧襯壓 ~ 廠獵蓋繭窪餘鏇簾淵製) 更多	-	2017-09-20
				Humira® (Humira®)	襯蓋鹽顧簾廠齋願鹹糧 = 鹹繭製選選製範夢醖製淵築廠窪鹹蓋壓築網糧 (構鹹衊積鹽製壓遞襯獵, 選築廠顧網壓餘餘鏇醖 ~ 淵鹹鹽鑰鹽蓋製糧鬱網) 更多
NCT02260791 (FKB327-002, EULAR2017)	临床3期	类风湿关节炎 C-reactive protein \| antidrug antibodies	730	FKB327	願憲選襯鹽衊簾築觸觸(襯鑰鹽淵繭觸鏇糧艱糧) = 築製鏇願窪餘艱鹽顧壓繭繭艱鹽廠憲範願糧衊 (鑰艱鏇窪觸襯蓋選築齋 )	积极	2017-06-14
				ADL	願憲選襯鹽衊簾築觸觸(襯鑰鹽淵繭觸鏇糧艱糧) = 顧網顧願壓獵壓獵膚構繭繭艱鹽廠憲範願糧衊 (鑰艱鏇窪觸襯蓋選築齋 )