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Related Experiment Videos

When biotech proteins go off-patent.

H Schellekens1

  • 1Central Laboratory, Animal Institute, Department of Innovation Studies, Utrecht University, PO Box 80190, 3508 TD Utrecht, The Netherlands. h.schellekens@gdl.uu.nl

Trends in Biotechnology
|July 31, 2004
PubMed
Summary

Biosimilar products face rigorous approval processes as patents expire for biologics like interferons and epoietins. Clinical studies and immunogenicity assessments are crucial for ensuring the safety and efficacy of these therapeutic proteins.

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Area of Science:

  • Biotechnology
  • Pharmacology
  • Immunology

Background:

  • Patents for first-generation recombinant DNA biologics (interferons, growth hormone, epoietins) are expiring.
  • This expiration allows for the introduction of biosimilar products into the market.
  • Generic drug approval pathways are not applicable to these complex biologics.

Purpose of the Study:

  • To discuss the regulatory considerations for biosimilar products.
  • To highlight the challenges in predicting the efficacy and safety of off-patent biologics.
  • To emphasize the importance of clinical studies and immunogenicity assessment for biosimilar approval.

Main Methods:

  • Review of regulatory requirements for biologics and biosimilars.
  • Analysis of physicochemical characterization, bioassays, and animal studies.

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  • Discussion of clinical trial necessity and immunogenicity evaluation.

    • Main Results:

    • Off-patent biologics require extensive documentation, including clinical studies, for marketing authorization.
    • Immunogenicity remains a significant concern, as exemplified by pure red cell aplasia (PRCA) linked to epoietin-alpha.
    • A risk-based approach is recommended for assessing antibody induction by biosimilars.

    Conclusions:

    • Biosimilar approval necessitates comprehensive data beyond physicochemical and preclinical studies.
    • Understanding and mitigating immunogenicity risks are paramount for therapeutic protein safety.
    • Rigorous evaluation is essential to ensure patient safety and therapeutic equivalence of biosimilar products.