Immunogenicity of BiosimilarsThursday, 21 July 2011 at 11:15 Add to Calendar ▼SELECTBIOenquiries@selectbiosciences.com Unwanted immunogenicity of biological medicines can be a serious problem and can be of concern to regulators. A carefully considered strategy and use of validated procedures is required for its assessment. The Biosimilars Working Party of the CHMP has drafted guidelines on unwanted Immunogenicity Assessment. Immunogenicity issues for biosimilars are broadly similar to those for innovator biologicals, but there are some differences in the way immunogenicity of biosimilars is assessed. These issues will be considered during the presentation. |