Biosimilars already approved and in development

Dörner, Thomas; Isaacs, John D.; Gonçalves, João; Azevedo, Valderílio Feijó; Castañeda‐Hernández, Gilberto; Strohal, Robert; McInnes, Iain B.

doi:10.1136/conmed-2017-100004

Cited by 6 publications

(4 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Currently, five TNF inhibitors are approved for the treatment of RA, including adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab [20]. Available biosimilars on the market include etanercept (four biosimilars), adalimumab (three biosimilars), infliximab (three biosimilars), and rituximab (one biosimilar), with additional biosimilars under investigation [21,22]. YLB113, which received approval for use as a biosimilar in Japan early in 2019, provides an additional alternative for the treatment of RA.…”

Section: Discussionmentioning

confidence: 99%

A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis

et al. 2019

View full text Add to dashboard Cite

Introduction: YLB113 is a biosimilar of the reference product (RP), etanercept, under development for treatment of patients with moderate-to-severe rheumatoid arthritis (RA) and other approved indications. A phase 3 study was conducted in Europe, Japan, and India to compare the efficacy, safety, and immunogenicity of YLB113 with the RP over a treatment period of 52 weeks. Methods:Overall, 528 patients with moderateto-severe RA receiving concomitant methotrexate were randomized to receive a once-weekly, subcutaneous dose of 50 mg YLB113 or the RP. The primary endpoint was ACR20 response rate at week 24, with similarity confirmed if the 95% confidence interval (CI) for YLB113 and the RP was within the range of -15 to 15%. Safety and immunogenicity endpoints were assessed to week 52. Results: Based on the European analysis, in the full analysis set, ACR20 response at week 24 was 83.3% and 88.5% for YLB113 and the RP, respectively. Responses were within the predefined clinical equivalence margin. The sensitivity analysis in the per protocol set revealed a similar proportion of subjects exhibiting ACR20 response at week 24 between groups, with a difference of -5.1% (95% CI -11.07 to 0.81).

show abstract

Section: Discussionmentioning

confidence: 99%

A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Enbrel seems to have slightly higher rates of immunogenicity than the biosimilars SB4, GP2015, and CHS0214,26–28 although conclusions cannot currently be drawn because immunogenicity does not seem to affect efficacy or safety in most of the biosimilar trials, and high concentrations of drug may interfere in the assay and lead to false negative ADA results29 (table 1). …”

Section: Considering Patient Managementmentioning

confidence: 99%

Biosimilars: considerations for clinical practice

et al. 2017

Self Cite

View full text Add to dashboard Cite

With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective.

show abstract

“…Weitere Untersuchungen zum Swichting von Biologika bei der rheumatoiden Arthritis, der ankylosierenden Spondylitis und der Psoriasisarthritis jeweils an erwachsenen Patienten wurde von T. Dörner aus Berlin zusammengefasst [4].…”

Section: Introductionunclassified

Biosimilars in der Kinderrheumatologie

Horneff¹

2021

Kinder- und Jugendmedizin

View full text Add to dashboard Cite

ZUSAMMENFASSUNGMit der Einführung von Biosimilars für Etanercept und Adalimumab können diese zur primären Therapie der juvenilen idiopathischen Arthritis eingesetzt werden oder durch Umstellung/Switch vom Originator auf ein Biosimilar. Bislang liegen nur begrenzte Daten über diesen Einsatz vor. Die Datenbank des nationalen BIKER-Registers wurde genutzt, um Erfahrungen aus der klinischen Praxis mit Etanercept- und Adalimumab-Biosimilars sowohl im head-to-head-Vergleich (n = 118) mit dem Originator als auch nach Switch (n = 117) zu beschreiben. Die Patientencharakteristika und Krankheitsaktivitätsparameter waren bei Therapiestart weitgehend vergleichbar. Kein Unterschied fand sich auch in der Effektivität. Ein Rückgang des JADAS10 zeigt eine vergleichbare Verbesserung in beiden Gruppen an. Auch Unterschiede in der Verträglichkeit ergaben sich nicht. Nach Switchung kann keine Verschlechterung der Krankheitsaktivität erkannt werden. Über besondere Hemmnisse bei der Anwendung von Biosimilars in der Kinderheumatologie kann nur spekuliert werden. Die bisherigen Erfahrungen sowohl bei der Ersteinstellung als auch beim Switching zu Biosimilars zeigen ermutigende Ergebnisse.

show abstract

Biosimilars already approved and in development

Cited by 6 publications

References 15 publications

A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis

A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis

Biosimilars: considerations for clinical practice

Biosimilars in der Kinderrheumatologie

Contact Info

Product

Resources

About