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Updated: Mar 7, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Biopharmaceuticals: Reference Products and Biosimilars to Treat Inflammatory Diseases
Ann Gils1, Antonio Bertolotto, Denis Mulleman
1*Department of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Leuven, Belgium; †Division of Neurology and Multiple Sclerosis Regional Center, AOU San Luigi, Orbassano, Turin, Italy; and Departments of ‡Rheumatology and §Pharmacovigilance, Université François-Rabelais de Tours, Tours, France.
Abstract:
Biopharmaceuticals are primarily therapeutic proteins developed to perform specific functions by acting on the disease pathophysiology. Compared with low-molecular chemically synthesized drugs, production of biopharmaceuticals is much more complex and routes of administration and pharmacokinetics differ. Biopharmaceuticals are blockbusters in the treatment of inflammatory diseases, such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases, and the introduction of these drugs has revolutionized treatment. Disadvantages include their high costs and the fact that they can evoke antidrug antibodies leading to decreased efficacy. Treatment can be optimized through the development of dosing algorithms and cost can be reduced by biosimilars, after a comparable biological activity, safety, and efficacy have been demonstrated.
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