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Comparison of Small Molecule Drugs and Biologic Products

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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/
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Comparison of Small Molecule Drugs and Biologic Products

  1. 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.

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