Biosimilars intermediate
Peptide Biosimilar Development
Regulatory and scientific considerations for developing biosimilar peptide therapeutics.
By Encyclopeptide Editorial | 1 min read
biosimilar development regulatory comparability follow-on
Overview
Biosimilar development for peptides requires demonstrating high similarity to an approved reference product.
Development Pathway
Analytical Similarity
- Structural characterization
- Functional assays
- Quality attributes comparison
Functional Similarity
- Bioassays
- Binding assays
Clinical Studies
- Pharmacokinetic studies
- Comparative clinical trial
- Immunogenicity studies
Regulatory Considerations
| Region | Pathway |
|---|---|
| US (FDA) | 351(k) |
| EU (EMA) | Biosimilar pathway |
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