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.

Start Date21 Nov 2022

Sponsor / Collaborator

Biocon Biologics, Inc.

[+2]

JPRN-jRCT2071200057 / CompletedPhase 1IIT

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

Start Date08 Jul 2017

Sponsor / Collaborator-

CTRI/2016/02/006625 / CompletedPhase 3

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

Start Date09 Aug 2016

Sponsor / Collaborator

Biocon Research Ltd.

100 Clinical Results associated with Adalimumab biosimilar (Biocon)

100 Translational Medicine associated with Adalimumab biosimilar (Biocon)

100 Patents (Medical) associated with Adalimumab biosimilar (Biocon)

Literatures (Medical) associated with Adalimumab biosimilar (Biocon)

01 Jan 2022·Journal of Colloid and Interface ScienceQ2 · CHEMISTRY

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

Q2 · CHEMISTRY

Article

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

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.

01 Nov 2015·Sheng wu gong cheng xue bao = Chinese journal of biotechnology

[Cloning and expression profile of Bmyan in the silkworm (Bombyx mori) and experimental validation as one target of microRNA 7].

Article

Author: Zhou, Lanting ; Liu, Shiping ; Xia, Qingyou ; Wu, Xiaoyan ; Yin, Jiyun ; Huang, Yaxi ; Wang, Wei

microRNAs (miRNAs) are an extensive class of -22-nucleotide (nt) endogenous noncoding RNAs regulating life activities ofmetazoans through binding to 3'-untranslated regions (3'-UTRs) of their target genes. This work aimed to identify yan gene in the silkworm, reveal its expression profile and confirm if it is one target of bmo-miR-7 and, as such, have potential for contributing to better understanding of the molecular mechanisms involved in the metamorphosis of silkworm. Based on homolog searching and PCR amplification, we cloned the coding sequence (CDS) of Bmyan, which encodes 476 amino acid residues and contains SAM-PNT and ETs domains. Quantitative PCR (q-PCR), RT-PCR and microarray data revealed high expression of Bmyan in the head, body wall and ovary of day-3 fifth instar larval silkworm, low or no expression in other tissues. It was lowly expressed in the early larval stages, but highly expressed from late spinning to day 4 pupa. The 3'-UTR of Bmyan was obtained by rapid-amplification of cDNA ends (3'RACE) and predicted to contain two potential recognition sites of bmo-miR-7. The luciferase reporter vector containing the 3'-UTR of Bmyan was constructed and co-transfected into BmE cell line with the mimic of bmo-miR-7 and the decreased relative activity of luciferase showed that Bmyan is one target of bmo-miR-7. This work helps further functional analysis of bmo-miR-7 and Bmyan in the silkworm.

01 Mar 2013·Russian Journal of Bioorganic Chemistry

Bmo-miR-9a down regulates the expression of Bm-ase Gene in vitro

Article

Author: Xingjia Shen ; Fei Song ; Xin Wang ; Shunming Tang ; Yong C Huang

MicroRNAs (miRNAs) are a class of non-protein coding small RNAs of 18-24 nucleotides in length that regulate expression of genes at post-transcriptional levels and play multiple roles in biological processes. Bm-ase plays an important role in the course of nerve development of the silkworm, Bombyx mori. Bmo-miR-9a is a conservative miRNA. By using target prediction software RNA22 and RNAhybrid, we found a target site of Bmo-miR-9a in the 3'UTR of Bm-ase gene. To verify the regulation function of Bmo-miR-9a on the expression of Bm-ase gene, a Bmo-miR-9a over-expressing vector and Bm-ase 3'UTR fused firefly luciferase gene reporter plasmid were constructed, respectively. Then they were used to co-transfect the BmN cells. The result showed that luciferase activity in the co-transfected cells was suppressed compared with the control. A similar result was obtained when BmN cells were co-transfected with artificial synthetic Bmo-miR-9a mimics and Bm-ase 3'UTR fused luciferase reporter plasmid. These results suggest that Bmo-miR-9a can down regulate the expression of Bm-ase gene.

News (Medical) associated with Adalimumab biosimilar (Biocon)

25 Sep 2024

·www.prnewswire.com

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

Phase 3Clinical ResultImmunotherapy

19 Jul 2024

·www.pharmaceutical-technology.com

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”.

BiosimilarDrug ApprovalGene Therapy

06 Mar 2024

·www.businesswire.com

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Psoriatic Arthritis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines. The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Psoriatic Arthritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Psoriatic Arthritis R&D. The therapies under development are focused on novel approaches to treat/improve Psoriatic Arthritis. Psoriatic Arthritis Emerging Drugs Chapters This segment of the Psoriatic Arthritis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Psoriatic Arthritis Emerging Drugs Sotyktu: Bristol Myers Squibb Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3. Currently, the drug is in the Phase III stage of its development for the treatment of Psoriasis Arthritis. HS-10374: Hansoh BioMedical R&D Company HS-10374 mechanism of action is to inhibit (TYK2) that is tyrosine-kinase 2. TYK2 inhibitors work by blocking the TYK2 protein and the cellular signals that run through it. Those signals can in turn activate other immune proteins and are associated with inflammation. Its route of administration is orally. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Psoriasis Arthritis. si-544: selection si-544, the Companys lead candidate, selectively blocks Kv1.3, a key ion channel expressed disease-associated effector memory T (TEM) cells. Kv1.3 is essential for the chronic activation and proliferation of these cells which escape the control of the immune system and become malignant. TEM cells drive inflammation in many autoimmune diseases, including atopic dermatitis, psoriasis, rheumatoid arthritis, and multiple sclerosis. Currently, the drug is in the Phase I stage of its development for the treatment of Psoriasis Arthritis. Psoriatic Arthritis: Therapeutic Assessment Major Players in Psoriatic Arthritis There are approx. 20+ key companies which are developing the therapies for Psoriatic Arthritis. The companies which have their Psoriatic Arthritis drug candidates in the most advanced stage, i.e. Phase III include, Bristol Myers Squibb. Phases The report covers around 25+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Psoriatic Arthritis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Psoriatic Arthritis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Psoriatic Arthritis drugs. Psoriatic Arthritis Report Insights Psoriatic Arthritis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Psoriatic Arthritis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Pfizer selectION Therapeutics GmbH Jiangsu HengRui Medicine Co., Ltd. Nimbus Lakshmi, Inc. Hansoh BioMedical R&D Company Bio-Thera Solutions Mylan Inc. ACELYRIN Inc. Key Products PF-06700841 si-544 SHR0302 NDI-034858 HS-10374 BAT2506 MYL-1401A ABY-035 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/v6c9p4 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Phase 1

100 Deals associated with Adalimumab biosimilar (Biocon)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Behcet's uveitis	JP	Fujifilm Kyowa Kirin Biologics Co., Ltd.	29 Jun 2020
Colitis, Ulcerative	JP	Fujifilm Kyowa Kirin Biologics Co., Ltd.	29 Jun 2020
Panuveitis	JP	Fujifilm Kyowa Kirin Biologics Co., Ltd.	29 Jun 2020
Rheumatoid Arthritis	JP	Fujifilm Kyowa Kirin Biologics Co., Ltd.	29 Jun 2020
Juvenile Idiopathic Arthritis	EU	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Juvenile Idiopathic Arthritis	LI	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Juvenile Idiopathic Arthritis	NO	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Juvenile Idiopathic Arthritis	IS	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Pediatric Crohn's Disease	NO	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Pediatric Crohn's Disease	IS	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Pediatric Crohn's Disease	EU	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Pediatric Crohn's Disease	LI	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Plaque psoriasis	EU	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Plaque psoriasis	IS	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Plaque psoriasis	NO	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Plaque psoriasis	LI	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Uveitis	IS	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Uveitis	NO	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Uveitis	EU	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018
Uveitis	LI	Biosimilar Collaborations Ireland Ltd.	17 Sep 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	IN	Biocon Ltd.	-
Rheumatoid Arthritis	Phase 2	DE	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	BG	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	UA	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	RU	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	PE	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	CL	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	ES	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	PL	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014
Rheumatoid Arthritis	Phase 2	RO	Fujifilm Kyowa Kirin Biologics Co., Ltd.	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05637515 (CTgov)	Phase 3	Plaque psoriasis	374	Humira (Group 1 :- Humira Continuously)	qzvphzaron(ltavmfsnty) = acokzaxlpg tozgkmehxd (yxaxhzkdqx, rkososripl - pnyqjgyuwe) View more	-	15 Oct 2024
				Hulio+Humira (Group 2:- Repeated Switches Humira - Hulio)	qzvphzaron(ltavmfsnty) = lnljhiigsa tozgkmehxd (yxaxhzkdqx, stdakkhgcq - iotsucdsls) View more
UEGW	Not Applicable	Inflammatory Bowel Diseases	-	Adalimumab originator	bnxvnuqhlf(ywdrvnpazi) = 33% stopped the biosimilar medication due to an allergic reaction oyiudeopft (bwovqsylyy ) View more	-	01 Oct 2020
				Adalimumab biosimilar (Hulio)
NCT02260791 (Pubmed \| J Rheumatol) Manual	Phase 3	Rheumatoid Arthritis	730	Methotrexate+Adalimumab-FKB-327	(vljjswytbb) = kmnwttczit omutkjutip (xnlpwsmmli )	Similar	12 Dec 2019
				Methotrexate+adalimumab	(vljjswytbb) = tzwjnwwrwn omutkjutip (xnlpwsmmli )
EULAR2019	Phase 3	Rheumatoid Arthritis	728	FKB327	(kjrfyhprck) = mzuqbaavog nhfnhlhsro (eozsfgrcis, 77.1 - 88.3) View more	Positive	12 Jun 2019
				Adalimumab RP	(kjrfyhprck) = qsstgxmmep nhfnhlhsro (eozsfgrcis, 74.8 - 90.4) View more
NCT02260791 (ARABESC \| FKB327-002, CTgov)	Phase 3	Rheumatoid Arthritis	728	FKB327 (FKB327)	hrbpcoryxr(zigvheitlp) = ofrvcpojuv ettcosmzpa (xquiyfvdzx, xmniemgqma - debokkbyak) View more	-	20 Sep 2017
				Humira® (Humira®)	hrbpcoryxr(zigvheitlp) = ocbbwmhkfy ettcosmzpa (xquiyfvdzx, xnkmzlryhr - mgsadywhff) View more
NCT02260791 (FKB327-002, EULAR2017)	Phase 3	Rheumatoid Arthritis C-reactive protein \| antidrug antibodies	730	FKB327	(gtmgecdmos) = odjxsptynp ntswrnkapi (simscpzxkj )	Positive	14 Jun 2017
				ADL	(gtmgecdmos) = dcoieoomby ntswrnkapi (simscpzxkj )

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