title: [Biosimilars and the efficiency principle].
abstract: Biosimilars are subject to the efficiency evaluation according to section 106 Social Code Book Five (SGB V). The specific evaluation method influences the physician's prescription behaviour. In the case of an individual prescription limit evaluation (Richtgrößenprüfung), the prescription of biosimilars would usually not result in recourse but, as a start, in the initiation of the evaluation proceedings. Starting from 2017, the individual prescription limit evaluation will be cancelled. The active ingredient evaluation (Wirkstoffprüfung) expected instead at a regional level may provide for biosimilar to original drug ratios and result in recourses if these ratios are missed. First agreements on specific evaluation proceedings at a regional level are expected for this year.
authors.affiliation: DIERKS + BOHLE Rechtsanwälte Partnerschaft mbB, Berlin, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Münnch
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D057915:Drug Substitution / Q000639:trends*; D005062:European Union; D019317:Evidence-Based Medicine; D006801:Humans; D007880:Legislation, Drug; D017063:Outcome Assessment, Health Care / Q000331:legislation & jurisprudence*; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals