Samsung adds 48-week extension to SB4 biosimilar study

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Samsung adds 48-week extension to SB4 biosimilar study

Biosimilares/Novedades | Posted 27/04/2015 0 Post your comment

Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid arthritis patients.

The study by South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis is ongoing and will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel (etanercept) in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The trial is a phase III, double blind, controlled, randomized, parallel-group, 2-arm, multicenter study. The main objective of the study is to demonstrate the equivalence of SB4 to Enbrel at Week 24, in terms of American College of Rheumatology 20% response criteria (ACR20) response rate in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy. Secondary objectives include ACR20 at Week 52, ACR50 at Week 24 and 52, Disease activity score based on a 28 joint count (DAS28) at Week 24 and 52 and collection of safety data including adverse events/serious adverse events throughout the study.

The trial is being carried out in Bulgaria, Colombia, Czech Republic, Hungary, India, Korea, Lithuania, Mexico, Poland, Ukraine and the UK. It was planned to enrol 498 patients, aged 18 years and above, with 357 coming from the European Economic Area.

The study, which was expected to be completed in November 2014, will now be extended in some countries. This means that after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will then receive SB4 for an additional 48 weeks.

Samsung Bioepis submitted an application for its etanercept biosimilar candidate, SB4, to the European Medicines Agency (EMA) in January 2015 [1]. The company also announced in March 2015 that its infliximab biosimilar candidate, SB2, had been accepted for review by EMA [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis submits second biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-submits-second-biosimilar-to-EMA

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Source: ClinicalTrials.gov