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Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer's
Hillel P Cohen1, Matthew Turner2, Dorothy McCabe3
1Sandoz Inc., Princeton, NJ, USA. hillel.cohen@sandoz.com.
Summary
Streamlining biosimilar approval processes can enhance patient access to affordable biological therapies. Removing redundant clinical trials and reconsidering interchangeability requirements will accelerate development without compromising safety or efficacy.
Area of Science:
- Pharmacoeconomics
- Regulatory Science
- Biopharmaceutical Development
Background:
- Biosimilars have been available for nearly two decades in Europe and over a decade in the USA, improving healthcare access and affordability.
- Despite their establishment, patient access to biological therapies remains a challenge in certain markets.
- There is a recognized need to optimize biosimilar development pathways without compromising quality, safety, or efficacy.
Purpose of the Study:
- To identify potential efficiencies within the biosimilar approval process.
- To propose revisions to clinical trial requirements and regulatory designations for biosimilars.
- To advocate for streamlined development to increase the availability of diverse biological drugs.
Main Methods:
- Analysis of the utility of different types of data in biosimilar assessment (biochemical, biophysical, functional assays vs. clinical efficacy endpoints).
- Evaluation of the regulatory value of immunogenicity studies and multiple-switch studies for interchangeability designation.
- Consideration of global approval standards, manufacturing change monitoring, and the role of real-world evidence.
Main Results:
- Biochemical, biophysical, and functional assays are more sensitive indicators of biosimilarity than clinical efficacy endpoints.
- Additional clinical efficacy studies and large immunogenicity studies offer limited regulatory value.
- Multiple-switch studies for US interchangeability designation and comparative pharmacokinetic testing between EU and US reference products are unnecessary.
Conclusions:
- Regulatory pathways for biosimilars should be streamlined by reducing redundant clinical trials.
- Interchangeability requirements, particularly multiple-switch studies, should be reconsidered and potentially eliminated.
- Leveraging real-world evidence and optimizing approval processes will accelerate the development of more biosimilars, enhancing patient access and affordability.
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