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In a study where individuals posing as strangers offered compliments and proposed casual sex to students, the responses differed significantly based on gender. Not a single woman accepted the proposal, while 70% of the men agreed. This outcome provides a useful scenario to explore through the lens of evolutionary psychology and social learning theory, highlighting the diverse perspectives on human sexual behaviors.
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Biosimilars: A Multidisciplinary Perspective.

Majed Khraishi1, David Stead2, Milan Lukas3

  • 1Clinical Professor of Medicine (Rheumatology), Memorial University of Newfoundland, Canada.

Clinical Therapeutics
|March 19, 2016
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Summary
This summary is machine-generated.

Biosimilars offer affordable biologic therapies, increasing patient access. This review details their development, clinical use, and regulatory approval, highlighting their potential to transform treatment across various medical fields.

Keywords:
Inflammatory Bowl Disease (IBD)Nephrologyarthritisbiosimilarspharmacovigilancesafety

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Area of Science:

  • Biopharmaceutical Science
  • Regulatory Science
  • Clinical Pharmacology

Background:

  • Biosimilars are regulated, approved copies of originator biologic therapies.
  • They offer improved affordability and wider patient access compared to biologics.
  • Regulatory guidelines for biosimilar development are rigorous and evolving.

Purpose of the Study:

  • To provide a comprehensive review of the biosimilar development and approval process.
  • To offer multidisciplinary guidance on the clinical application and therapeutic utility of biosimilars.
  • To address the underrecognition of biosimilars in clinical practice.

Main Methods:

  • Review of regulatory guidelines and approval processes for biosimilars.
  • Analysis of nonclinical and clinical evaluation steps for demonstrating comparability.
  • Expert discussions on clinical developments across gastroenterology, nephrology, oncology, and rheumatology.

Main Results:

  • Over 20 biosimilars approved in Europe, including monoclonal antibody biosimilars.
  • Demonstration of quality, efficacy, and safety comparability is required for licensing.
  • Clinical application of biosimilars is underrecognized by physicians.

Conclusions:

  • Biosimilars have significant potential to broaden access to biologic therapies.
  • Ongoing pharmacovigilance, clinical studies, and real-world data are crucial for long-term risk-benefit assessment.
  • Multidisciplinary guidance is needed to facilitate the integration of biosimilars into clinical practice.