Biosimilars or Follow-on Biologics: Scientific and Regulatory ConsiderationsBiopharmaceuticals represent one of the most promising frontiers in pharmacotherapy and appear to be the way of the future as they have revolutionized health care with effective, targeted therapies designed to treat costly and complex diseases such as cancer, Parkinson’s, Alzheimer’s and rheumatoid arthritis. |
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Immunogenicity and Biosimilar Protein DevelopmentImmunogenicity is the ability of a therapeutic drug to elicit an immune response, specifically the production of antibodies, in study subjects. An antibody response specific for a therapeutic protein can range from the production of clinically irrelevant antibodies with no impact on drug distribution, clearance, or efficacy to a severe anti-drug antibody response that manifests in serious safety issues. |
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ICON ProfileTim Clark - Vice President, Biosimilars Development, ICON plc |
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Did you know?Fast Facts. |
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