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The global landscape on interchangeability of biosimilars
Anurag S Rathore1, James G Stevenson2, Hemlata Chhabra1
1Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
Expert Opinion on Biological Therapy
|February 11, 2021
Summary
Biosimilars can improve healthcare affordability and access. Global harmonization on biosimilar interchangeability is crucial for wider adoption and better biologic accessibility, supported by real-world evidence.
Area of Science:
- Pharmacoeconomics
- Biopharmaceutical policy
- Drug regulation
Background:
- Biosimilars offer potential for increased affordability and accessibility of biotherapeutics.
- Successful biosimilar adoption hinges on regulatory, payor, and policymaker engagement.
- Interchangeability of biosimilars remains a key point of discussion.
Purpose of the Study:
- To review regulatory stances on biosimilar interchangeability.
- To discuss outstanding issues regarding biosimilar interchangeability.
- To highlight the need for global harmonization on interchangeability.
Main Methods:
- Review of major regulatory body positions on biosimilar interchangeability.
- Analysis of real-world case studies (adalimumab, etanercept) for interchangeability considerations.
- Discussion of key issues and global harmonization needs.
Main Results:
- Regulatory perspectives on interchangeability vary.
- Real-world data supports switching to biosimilars.
- Global harmonization is needed to accelerate adoption.
Conclusions:
- Global harmonization of interchangeability can enhance biologic accessibility.
- Post-marketing pharmacovigilance is essential for long-term risk-benefit assessment.
- Real-world experience supports switching from originators to biosimilars.
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