title: [What doctors need to know about biosimilar medicinal products?].
abstract: Biological drug is a drug containing one or more active substances produced or secreted from a biological source. Some of them may be previously present in the human body, and examples include proteins such as insulin, growth hormone or erythropoetin. Biosimilar drug is a medical product that is a copy of the original approved drug whose patent has expired. Strict rules apply to similar biological medicines: 1) it is unable to support extrapolation of data on safety and efficacy between individual indications, except in the case of appropriate, science-based evidence; 2) biosimilar drugs must meet the requirements associated with testing the immunogenicity and safety monitoring afterthe introduction of the drug in clinical practice, including the risk management program; 3) each biosimilar drug has to be labeled under its own name in order to allow clear traceability of all medications; and 4) the principle of automatic substitution cannot apply to biosimilar drugs because they are not interchangeable.
authors.forename: Petar
authors.initials: P
authors.lastname: Kes
authors.forename: Ines
authors.initials: I
authors.lastname: Mesar
authors.forename: Nikolina
authors.initials: N
authors.lastname: Bašić-Jukić
authors.forename: Sanjin
authors.initials: S
authors.lastname: Rački
mesh_terms: D001291:Attitude of Health Personnel; D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D017277:Drug Approval; D011307:Drug Prescriptions / Q000592:standards*; D013006:Growth Hormone / Q000592:standards; D007722:Health Knowledge, Attitudes, Practice; D019382:Human Growth Hormone / Q000592:standards; D006801:Humans; D010819:Physician's Role; D017410:Practice Guidelines as Topic; D011361:Professional Competence
chemical_list: D059451:Biosimilar Pharmaceuticals; D019382:Human Growth Hormone; D013006:Growth Hormone