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Small
Molecular Weight
Manufacturing
Size
Structure
Manufacturing Quality Tests
Approval Requirements
Mode of Administration
Large
4,000 to > 140,000 Daltons < 500 - 900 Daltons
Complex with potential
structural variations
Simple and well defined
Specialized biological process to
make similar copy
Predictable chemical process to
make identical copy
≥ 250
≤ 50
Large clinical trials in patients
Usually requires injection or infusion
Small clinical trials in
healthy volunteers
Usually amenable to ingestion
VSBIOSIMILARS GENERICS
Comparison of Traditional Small Molecule
Drugs and Biologic Agents
www.biolink.us
Immunogenic
Stable
Chemical
Non Immunogenic
Unstable
Protein
www.biolink.us Comparison of Traditional Small Molecule Drugs and Biologic Agents
1. Amgenbiosimilars.com. Biosimilars Versus Generics. 2015. Available at: http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/. Accessed April 27, 2015.
2. Understanding Key Differences Between Biosimilars And Small Molecule Generics. 1st ed. New York City: McMahon; 2013:8.

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Comparison of Small Molecule Drugs and Biologic Products

  • 1. Small Molecular Weight Manufacturing Size Structure Manufacturing Quality Tests Approval Requirements Mode of Administration Large 4,000 to > 140,000 Daltons < 500 - 900 Daltons Complex with potential structural variations Simple and well defined Specialized biological process to make similar copy Predictable chemical process to make identical copy ≥ 250 ≤ 50 Large clinical trials in patients Usually requires injection or infusion Small clinical trials in healthy volunteers Usually amenable to ingestion VSBIOSIMILARS GENERICS Comparison of Traditional Small Molecule Drugs and Biologic Agents www.biolink.us Immunogenic Stable Chemical Non Immunogenic Unstable Protein www.biolink.us Comparison of Traditional Small Molecule Drugs and Biologic Agents 1. Amgenbiosimilars.com. Biosimilars Versus Generics. 2015. Available at: http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/. Accessed April 27, 2015. 2. Understanding Key Differences Between Biosimilars And Small Molecule Generics. 1st ed. New York City: McMahon; 2013:8.