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Published on: May 4, 2017
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Biosimilars: From Extrapolation into Off Label Use.
Sizheng Zhao1,2, Jagdish R Nair2, Robert J Moots1,2
1Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.
Current Pharmaceutical Design
|December 1, 2017
Summary
Biosimilars offer expanded access to biologic treatments for inflammatory conditions. While concerns exist regarding indication extrapolation, post-marketing surveillance is crucial for ensuring safety and efficacy.
Area of Science:
- Immunology
- Pharmacology
- Biotechnology
Background:
- Biologic drugs have transformed inflammatory condition management.
- Patent expirations have led to the development of biosimilars, which are highly similar but non-identical molecules.
- Extrapolation of indications is a key concept in biosimilar development, but raises concerns about efficacy and immunogenicity.
Purpose of the Study:
- To revisit the concepts of biosimilarity and extrapolation of indications.
- To examine concerns surrounding extrapolation using biosimilar infliximab (CT-P13) as an example.
- To review the opportunities and cautions for using biologics and biosimilars in unlicensed inflammatory conditions.
Main Methods:
- A narrative overview based on literature search and author experience.
- Literature search conducted using PubMed, Web of Science, and regulatory agency archives (FDA, EMA).
Main Results:
- Concerns regarding biosimilar extrapolation were analyzed concerning mechanisms of action, immunogenicity, and clinical trial design.
- The review explored the potential for biosimilars to improve access to treatments for rare inflammatory conditions and for off-label use.
Conclusions:
- Biosimilars present opportunities to enhance treatment access and options, particularly for rare diseases and off-label applications.
- Balancing the benefits of biosimilars with the risks of off-label prescribing is essential.
- Robust post-marketing surveillance is critical for establishing long-term evidence of biosimilar efficacy and safety.
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