The goal of this non interventional study is to evaluate the use of Tyenne, a tocilizumab biosimilar, in a real world setting in Rheumatoid Arthritis (RA) patients over a period of 12 months.
The main questions it aims to answer are:
What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 6 months after treatment start?
What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 12 months after treatment start?
The decision of prescribing Tyenne will be done by the physician independently, prior to patient enrolment in the study. Enrolled patients will be followed for 12 months following Tyenne treatment start, or until they permanently discontinue Tyenne.
There will be one baseline visit and three follow-up visits at approximately 3, 6 and 12 months after Tyenne treatment initiation. All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol.

开始日期2024-03-05

申办/合作机构

Fresenius Kabi SwissBioSim GmbH

NCT04934072 / Completed临床3期

A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks.
At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks.
Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period.
For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

开始日期2021-07-05

申办/合作机构

Fresenius Kabi SwissBioSim GmbH

EUCTR2019-004369-42-CZ / Not yet recruiting临床3期

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I

开始日期2020-09-01

申办/合作机构

Fresenius Kabi SwissBioSim GmbH

100 项与 Fresenius Kabi SwissBioSim GmbH 相关的临床结果

登录后查看更多信息

0 项与 Fresenius Kabi SwissBioSim GmbH 相关的专利（医药）

登录后查看更多信息

项与 Fresenius Kabi SwissBioSim GmbH 相关的文献（医药）

2024-12-31·Journal of Medical Economics

Modelling the opportunity for cost-savings or patient access with biosimilar adalimumab and tocilizumab: a European perspective

Article

作者: Shastri, Kunal ; Ainslie-Garcia, Margaret ; Ferko, Nicole ; Clarke, Kerise

OBJECTIVESBiosimilars improve patient access by providing cost-effective treatment options. This study assessed the potential for savings and expanded patient access with increased use of two biosimilar disease modifying anti-rheumatic drugs (DMARDs): (a) approved adalimumab biosimilars and (b) the first tocilizumab biosimilar, representing an established biosimilar field and a recent biosimilar entrant in France, Germany, Italy, Spain, and the United Kingdom (UK).METHODSSeparate ex-ante analyses were conducted for each country, parameterized using country-specific list prices, unit volumes annually, and market shares for each therapy. Discounting scenarios of 10%, 20%, and 30% were tested for tocilizumab. Outputs included direct cost-savings associated with drug acquisition or the incremental number of patients that could be treated if savings were redirected. Two biosimilar conversion scenarios were tested.RESULTSSavings associated with a 100% conversion to adalimumab biosimilar ranged from €10.5 to €187 million (UK and Germany, respectively), or an additional 1,096 to 19,454 patients that could be treated using the cost-savings. Introduction of a tocilizumab biosimilar provided savings up to €29.3 million in the most conservative scenario. Exclusive use of tocilizumab biosimilars (at a 30% discount) could increase savings to €28.8 to €113 million or expand access to an additional 43% of existing tocilizumab users across countries.CONCLUSIONThis study demonstrates the benefits that can be realized through increased biosimilar adoption, not only in an untapped tocilizumab market, but also through incremental increases in well-established markets such as adalimumab. As healthcare budgets continue to face downwards pressure globally, strategies to increase biosimilar market share could prove useful to help manage financial constraints.

2024-04-01·BioTechniques

An Industry Perspective Approach and Control Strategy for Implementation of Ready-to-Use Cells in Bioassays: Survey Outcome And Recommendations

Article

作者: Haenssen, Keneshia K ; White, John R ; Cheng, Zhijie Jey ; Wang, Jenny ; Kozminsky-Atias, Adi ; Ong, Esther HQ ; Martinez, Eva ; Qahwash, Isam ; Day, Peter ; Ahmed, Sammina ; Bennington, Petra ; Stokes, Elaine SE ; Amstrup, Jan

The BioPhorum Development Group is an industry collaboration enabling the sharing of common practices for the development of biopharmaceuticals. Bioassays are an important part of an analytical control system. Utilization of ready-to-use cells can increase operational flexibility and improve efficiency by providing frozen cell banks uniform stock while removing challenges associated with maintaining cultured cells. The BioPhorum Development Group-Bioassay workstream conducted an intercompany benchmarking survey and group discussions around the use of ready-to-use cells for bioassays. The results of the collaboration provide alignment on nomenclature, production, qualification and implementation of ready-to-use cells to support the assay life cycle.

2024-03-01·Journal of Pharmaceutical Sciences

An Industry Perspective on the use of Forced Degradation Studies to Assess Comparability of Biopharmaceuticals

Article

作者: Nowinski, Ann K ; Colombo, Stefano ; Hübner, Göran ; Vo, Laila R ; Stokes, Elaine S E ; Singh, Surinder M ; Filoti, Dana I ; Magnenat, Laurent ; Pavon, Jorge Alex ; Woods, Joshua M ; Doyle, Jamie L ; Campbell, John M

Forced degradation, also known as stress testing, is used throughout pharmaceutical development for many purposes including assessing the comparability of biopharmaceutical products according to ICH Guideline Q5E. These formal comparability studies, the results of which are submitted to health authorities, investigate potential impacts of manufacturing process changes on the quality, safety, and efficacy of the drug. Despite the wide use of forced degradation in comparability assessments, detailed guidance on the design and interpretation of such studies is scarce. The BioPhorum Development Group is an industry-wide consortium enabling networking and sharing of common practices for the development of biopharmaceuticals. The BioPhorum Development Group Forced Degradation Workstream recently conducted several group discussions and a benchmarking survey to understand current industry approaches for the use of forced degradation studies to assess comparability of protein-based biopharmaceuticals. The results provide insight into the design of forced degradation studies, analytical characterization and testing strategies, data evaluation criteria, as well as some considerations and differences for non-platform modalities (e.g., non-traditional mAbs). This article presents survey responses from several global companies of various sizes and provides an industry perspective and experience regarding the practicalities of using forced degradation to assess comparability.

项与 Fresenius Kabi SwissBioSim GmbH 相关的新闻（医药）

2022-12-15

·BioPharmaDive

Another Humira biosimilar approved by FDA as AbbVie patent expiry looms

Dive Brief:Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company wont launch Idacio in the U.S. until July.Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.Dive Insight:The end of AbbVies monopoly promises to be a major event for the pharmaceutical industry. Humira brought in almost $21 billion in sales last year, including more than $17 billion in the U.S. For years, AbbVie has carefully built a wall of patent protections around the drug, extending its market exclusivity well beyond the main U.S. patents expiration in 2016.Amgen will be the first company to challenge AbbVie when it introduces its Amjevita biosimilar next month. A raft of other copycat versions now including Idacio will enter the market in July.While the biosimilars will likely cost less than Humira, the question is how far the challenger companies will go in cutting a list price that for the branded drug now reaches almost $80,000 a year. Drug rebating is also likely to factor into companies competitive calculus as they seek to challenge AbbVie.So far, the biosimilar market has failed to deliver on the promise of massive cost savings, but no drug has faced the volume of competition that will confront Humira starting in July.The FDA has cleared 40 biosimilar products to date, including eight that will take on Humira. Another copycat Humira product from Alvotech may win clearance this month, although it hit a setback earlier this year due to deficiencies in the companys manufacturing plant. Alvotech intends to launch its version in July, if approved.FDA-approved Humira biosimilarsDrug nameApproval dateExpected launch dateCompanyAmjevitaSeptember 2016Jan. 31, 2023AmgenCyltezoAugust 2017 (first approval)July 1, 2023Boehringer IngelheimHyrimozOctober 2018Sept. 30, 2023NovartisHadlimaJuly 2019June 30, 2023Samsung Bioepis, OrganonAbriladaNovember 2019As early as July 2023PfizerHulioJuly 2020July 31, 2023ViatrisYusimryDecember 2021July 1, 2023Coherus BioSciencesIdacioDecember 2022July 1, 2023Fresenius KabiSource: FDA '

上市批准专利到期专利侵权生物类似药

100 项与 Fresenius Kabi SwissBioSim GmbH 相关的药物交易

登录后查看更多信息

100 项与 Fresenius Kabi SwissBioSim GmbH 相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2024年12月22日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床3期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

地舒单抗生物类似药(Fresenius Kabi SwissBioSim) ( RANKL )	绝经期后骨质疏松更多	临床3期
阿达木单抗生物类似药(Merck Serono SA) ( TNF-α )	-	无进展
培非格司亭生物类似药(Fresenius Kabi) ( CSF-3R )	-	无进展
托珠单抗生物类似药(Fresenius Kabi ) ( IL-6RA )	-	无进展