Comparison of Small Molecule Drugs and Biologic Products
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- 1. Small Molecular Weight Manufacturing Size Structure Manufacturing Quality Tests Approval Requirements Mode of Amministration 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.