The author discusses controversies over the approval of 'biosimilars' under the headings: major objections to biosimilars; pamphlets; EMEA's role in establishing the 'biosimilarity exercise'; Food and Drug Administration (FDA); the need for publicly available data; biosmilars - a case for clinical pharmacology and clinical pharmacy; pharmacokinetics vs pharmacodynamics; physicochemical characterisation; role of scientific organisations and opinion leaders; biosmilars and the 'missing clinical experience'; ethics of publishing and author responsibility. (24 refs.)