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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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PF-05280014: A Trastuzumab Biosimilar.

Julia Paik1

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

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|October 4, 2018
PubMed
Summary

PF-05280014 (Trazimera™) is a biosimilar to trastuzumab, approved for HER2-positive breast and gastric cancers. Clinical studies confirm its similar efficacy, safety, and pharmacodynamics, offering a comparable treatment option.

Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • Trastuzumab is a critical anti-HER2 antibody for HER2-positive cancers.
  • The development of biosimilars offers potential for increased patient access and cost-effectiveness.

Purpose of the Study:

  • To evaluate PF-05280014 (Trazimera™) as a biosimilar to trastuzumab.
  • To confirm its efficacy, safety, and pharmacokinetic profile in approved indications.

Main Methods:

  • Comparative physicochemical and pharmacodynamic assessments.
  • Pharmacokinetic studies in healthy volunteers and patients with HER2-positive breast cancer.
  • Efficacy, immunogenicity, tolerability, and safety evaluations.

Main Results:

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  • PF-05280014 demonstrated similar physicochemical and pharmacodynamic properties to trastuzumab.
  • Pharmacokinetic similarity was established in relevant populations.
  • Equivalent efficacy in metastatic and comparable efficacy in early HER2-positive breast cancer was observed.
  • Similar immunogenicity, tolerability, and safety profiles were confirmed.

    • Conclusions:

    • PF-05280014 is a highly similar biosimilar to trastuzumab.
    • It provides an effective and comparable therapeutic option for HER2-positive breast and gastric cancers.
    • This biosimilar expands treatment choices for patients requiring anti-HER2 therapy.