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Etanercept (SB4): A Review in Autoimmune Inflammatory Diseases
Celeste B Burness1, Sean T Duggan2
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. demail@springer.com.
Summary
Etanercept (SB4) [Benepali®] is a biosimilar demonstrating therapeutic equivalence to reference etanercept [Enbrel®]. Clinical trials confirm similar efficacy and safety profiles in autoimmune inflammatory diseases.
Area of Science:
- Immunology
- Rheumatology
- Pharmacology
Background:
- Etanercept (SB4) [Benepali®] is a biosimilar to reference etanercept [Enbrel®].
- It is approved in the EU for rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and plaque psoriasis.
Purpose of the Study:
- To demonstrate the similarity of etanercept (SB4) to reference etanercept.
- To evaluate the quality, biological activity, efficacy, safety, and immunogenicity of etanercept (SB4).
Main Methods:
- Two clinical trials were conducted in healthy volunteers and patients with rheumatoid arthritis.
- Comparisons included pharmacokinetic properties, efficacy, safety, and immunogenicity over 52 weeks, with an open-label extension to 100 weeks.
Main Results:
- Etanercept (SB4) showed equivalent pharmacokinetic properties in healthy volunteers.
- Efficacy was similar in patients with rheumatoid arthritis, with sustained effects up to 52 weeks.
- The safety profile and immunogenicity were comparable to reference etanercept, with no adverse changes upon switching.
Conclusions:
- Etanercept (SB4) is a therapeutically equivalent alternative for adult patients with autoimmune inflammatory diseases.
- The biosimilar demonstrates comparable quality, efficacy, safety, and immunogenicity to reference etanercept.
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