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Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

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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Related Experiment Video

Updated: May 29, 2026

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization

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Biosimilars--global issues, national solutions.

Ivana Knezevic¹, Elwyn Griffiths

¹Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards Team, World Health Organization, Avenue Appia, Geneva, Switzerland. knezevici@who.int

Biologicals : Journal of the International Association of Biological Standardization

|September 20, 2011

Summary

This summary is machine-generated.

The development of biosimilars, or similar biotherapeutic products, presents significant regulatory and scientific challenges. Evaluating their quality, safety, and efficacy requires careful consideration due to inherent biological variability.

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Area of Science:

Biopharmaceutical development
Regulatory science
Drug manufacturing

Background:

Biotechnology-derived medicines have transformed patient care for severe diseases.
The biopharmaceutical market is rapidly expanding, driven by innovative biologicals.
Patent expiries for first-generation biopharmaceuticals necessitate the development of follow-on products.

Purpose of the Study:

To provide an overview of the scientific and regulatory hurdles in developing similar biotherapeutic products.
To introduce key challenges in the evaluation of biosimilars for global markets.
To set the stage for a series of articles on similar biotherapeutic products.

Main Methods:

Review of international consultations and regulatory discussions since 2004.
Analysis of the complexities in licensing biological copy products.
Identification of key issues in the regulatory evaluation of biosimilars.

Main Results:

Increased understanding of the challenges in assessing biosimilar quality, safety, and efficacy.
Facilitated information exchange among international regulators.
Identification of critical scientific and regulatory issues for biosimilar development.

Conclusions:

Developing and evaluating biosimilars involves unique scientific and regulatory complexities.
International collaboration has improved the understanding of biosimilar assessment.
Addressing these challenges is crucial for the global availability of safe and effective biosimilars.