Update on the safety and bioequivalence of biosimilars – focus on enoxaparin

Figures & data

Table 1 Characteristics of biologic drugs

1. Manufactured in or derived from microorganisms, plant cells, or animal cells.

2. Large, complex molecules or mixtures of molecules that can be difficult to fully characterize.

3. Encompass antibodies, polysaccharides, polynucleotides, proteins, and live viral material.

4. Increased potential for immunogenicity compared to small molecule drugs.

5. Potentially less stable than small molecule drugs.

Table 2 FDA criteria for demonstration of sameness of enoxaparin active ingredient⁷²

1. Equivalence of physicochemical properties.

2. Equivalence of source material and the method of depolymerization.

3. Equivalence of disaccharide building blocks and oligosaccharide sequence.

4. Equivalence in biochemical and biologic assays.

5. Equivalence of in vivo pharmacodynamic profile.

ThrockmortonDFDA response to Citizen Petition, Docket No. FDA-2003-P-0273RockvilleUS Food and Drug Administration2010 Available from: http://www.fda.gov/downloads/Drugs/DrugSafety/Postmarket/UCM220083.pdfAccessed May 5, 2013

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