The challenges of immunogenicity in developing biosimilar products.
Unwanted immunogenicity is a significant issue affecting most biotherapeutic products, including subsequent entry biological (SEB) medicines. Such immunogenicity can be associated with adverse reactions and can cause impaired clinical responses to the biotherapeutic. This feature article provides an overview of the challenges facing the biotechnology industry with regard to the prediction and assessment of immunogenicity of SEBs and, in particular, biosimilar products. In addition, the available guidance on assessing the immunogenicity of biotherapeutic products is discussed.
Wadhwa
Meenu
M
National Institute for Biological Standards and Control, Hertfordshire, UK.
Thorpe
Robin
R
D000818:Animals; D000906:Antibodies / Q000032:analysis; D000917:Antibody Formation / Q000187:drug effects / Q000276:immunology*; D017277:Drug Approval; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007118:Immunoassay; D011994:Recombinant Proteins / Q000009:adverse effects* / Q000276:immunology
D000906:Antibodies; D011994:Recombinant Proteins