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Related Concept Videos

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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Related Experiment Video

Updated: Feb 22, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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GP2015: An Etanercept Biosimilar.

Emma D Deeks1

  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|September 24, 2017
PubMed
Summary

GP2015, a biosimilar of etanercept, demonstrates equivalent efficacy and similar safety profiles in treating inflammatory autoimmune conditions. Switching between GP2015 and etanercept showed no adverse effects, offering a viable alternative therapy.

Area of Science:

  • Immunology
  • Pharmacology
  • Biochemistry

Background:

  • Etanercept, a p75 TNF receptor-Fc fusion protein, is a well-established therapy for inflammatory autoimmune diseases.
  • The development of biosimilars offers alternative treatment options with comparable therapeutic profiles.

Purpose of the Study:

  • To evaluate GP2015, a biosimilar of etanercept, for its efficacy, safety, tolerability, and immunogenicity.
  • To assess the impact of switching between GP2015 and reference etanercept.

Main Methods:

  • Comparative analysis of physiochemical and pharmacodynamic properties.
  • Pharmacokinetic studies in healthy volunteers.
  • Clinical trials assessing efficacy, safety, tolerability, and immunogenicity in patients with plaque psoriasis.

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  • Switching studies evaluating clinical outcomes.

    • Main Results:

    • GP2015 exhibits similar physiochemical and pharmacodynamic properties to etanercept.
    • Pharmacokinetic biosimilarity was established in healthy volunteers.
    • GP2015 demonstrated equivalent clinical efficacy to etanercept in moderate-to-severe plaque psoriasis.
    • Tolerability, safety, and immunogenicity profiles were comparable between GP2015 and etanercept.
    • Switching between the two agents did not affect clinical efficacy, tolerability, or immunogenicity.

    Conclusions:

    • GP2015 is a safe and effective biosimilar alternative to etanercept for approved indications.
    • The established role of etanercept in managing inflammatory autoimmune conditions is complemented by GP2015.
    • Switching between etanercept and its biosimilar GP2015 is clinically feasible without compromising patient outcomes.