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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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SB2: An Infliximab Biosimilar.

Yvette N Lamb1, Lesley J Scott2, Emma D Deeks2

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

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This summary is machine-generated.

SB2, a biosimilar of infliximab, demonstrated similar efficacy and safety profiles in clinical studies. Switching from reference infliximab to SB2 did not affect patient outcomes, offering a comparable treatment option.

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Area of Science:

  • Immunology
  • Pharmacology
  • Biotechnology

Background:

  • Reference infliximab is a crucial biologic therapy for autoimmune inflammatory conditions.
  • Biosimilars offer potential for increased patient access and cost savings in healthcare.

Purpose of the Study:

  • To evaluate the biosimilarity of SB2 to the reference anti-tumor necrosis factor-alpha (TNF-α) antibody, infliximab.
  • To assess the efficacy, safety, and immunogenicity of SB2 in patients with moderate to severe rheumatoid arthritis.

Main Methods:

  • Preclinical characterization comparing SB2 and reference infliximab.
  • Pharmacokinetic studies in healthy volunteers.
  • Clinical trials in rheumatoid arthritis patients, including switching studies from reference infliximab to SB2.

Main Results:

  • SB2 showed similarity to reference infliximab in preclinical characterization.
  • Pharmacokinetic and clinical studies demonstrated biosimilarity, with equivalent efficacy and comparable safety and immunogenicity profiles.
  • Switching from reference infliximab to SB2 was well-tolerated and did not impact clinical outcomes.

Conclusions:

  • SB2 is a highly similar biosimilar to reference infliximab.
  • SB2 provides a safe and effective therapeutic alternative for patients requiring infliximab treatment for autoimmune inflammatory diseases.