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Purpose  Biotechnological substances (BS) have rapidly expanded their clinical use. In parallel, there is an increase in expected or unexpected immunological or non-immunological adverse effects. In this part of the review, the current nomenclature of BSs, the classification of hypersensitivity reactions (HSR), as well as diagnostic and treatment approaches are documented to provide the tools to understand the nomenclature used throughout the databases and the need to harmonize it where applicable.    Methods  Detailed searches were performed on Pubmed, Web of Science, and Google Scholar to include all available publications. The search terms, such as specific BS, allergy, anaphylaxis, hypersensitivity, reactions, classification, diagnosis, grading, management, and desensitization, were determined for the search. Case reports, articles, and reviews on this subject were included.    Results  Today, a variety of non-standardized methods are used to support the clinical diagnosis. These include prick-to-prick tests and intradermal tests with the drug itself and its potentially allergenic ingredients. More rarely, anti-drug antibodies are detected and basophil activation tests are used by centers with research facilities. Although the treatment protocols for acute conditions vary, the overall approach is the same.    Conclusion  HSRs to BS are gradually increasing with the widening of their clinical use and indications. It is very important to prevent HSRs and to know the degree of severity as well as the emergency treatment algorithm. This review summarizes the diagnostic tests that should be applied: (a) immediately during/after a reaction, and (b) subsequently, and in the case that a switch of BS is not possible, desensitization is an option.

Hypersensitivity reactions to biologics (part II): classifications and current diagnostic and treatment approaches