Recent surveys indicate that physicians in the US and Europe are still unclear on what a biosimilar is – even those physicians who prescribe biologic medicines. See the infographic for a deeper look at the differences between biosimilar and generic medicines. Get the latest on Biosimilars at https://www.smallworldsocial.com/biolink/ Curated resources updated daily.

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.