comparison of small molecule drugs and biologic products

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 VS BIOSIMILARS 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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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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