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Updated: May 12, 2026
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Development and regulation of biosimilars: current status and future challenges
Asterios S Tsiftsoglou1, Sol Ruiz, Christian K Schneider
1Laboratory of Pharmacology, Department of Pharmaceutical Sciences, Aristotle University of Thessaloniki, 54124, Thessaloniki, Greece. tsif@pharm.auth.gr
Summary
Biosimilars, copy versions of original biologics, offer therapeutic alternatives. Their regulation, particularly in the EU, focuses on ensuring quality and comparability to reference products.
Area of Science:
- Biotechnology and Pharmaceutical Sciences
- Regulatory Affairs and Health Policy
Background:
- Original biopharmaceuticals, developed using rDNA technology, have been crucial in treating severe diseases since the 1980s.
- Patent expirations enable the development of biosimilars, offering similar biologic activity to original biopharmaceuticals.
- Biosimilars are expected to increase market competition, drive innovation, and support healthcare systems.
Purpose of the Study:
- To review the current regulatory status of biosimilars in the European Union (EU).
- To identify future challenges in the marketing authorization of biosimilars.
- To emphasize quality requirements for biosimilar medicinal products.
Main Methods:
- Analysis of the regulatory framework established by the European Union for biosimilar marketing authorization.
- Review of guidelines from the Committee for Medicinal Products for Human Use (CHMP) and scientific advice from the European Medicines Agency (EMA).
- Focus on quality, preclinical, and clinical comparability exercises required for biosimilar approval.
Main Results:
- The EU has pioneered a regulatory framework for biosimilars, a term also adopted by the US FDA.
- Biosimilar regulation is complex due to the high molecular weight and structural complexity of protein-based medicines.
- A comprehensive comparability exercise is essential to demonstrate similar efficacy and safety to the reference product.
Conclusions:
- Biosimilar regulation requires rigorous assessment to ensure product quality and therapeutic equivalence.
- Ongoing challenges exist in refining regulatory requirements for biosimilars.
- Emphasis on quality attributes is paramount for the successful development and approval of biosimilars.
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