title: Current regulatory and scientific considerations for approving biosimilars in Iran.
abstract: With the expiration of patents on the first generation of rDNA biopharmaceuticals, competitors began to introduce biosimilar products. The concept of generics as applied to classical chemical drugs cannot be used for biotechnology products. Physicochemical characterization, bioassays and animal studies do not have the ability to predict reliably the safety and efficacy of biotherapeutics. Clinical studies are always necessary. While regulators all over the world were really in need of a comprehensive guideline in this area, WHO introduced a guideline which is principally a basis for regulating biosimilars and is applicable in Iran, as well as many other countries.
authors.affiliation: National Drug Selection Council Secretariat, Pharmaceutical and Narcotic Affairs Department, Food and Drugs Organization, Ministry of Health and Medical Education, Fakhr-e-Razi Street, Enghlab Avenue, Tehran, Iran. hadavandn@yahoo.com
authors.forename: Naser
authors.initials: N
authors.lastname: Hadavand
authors.forename: Mahboubeh
authors.initials: M
authors.lastname: Valadkhani
authors.forename: Aida
authors.initials: A
authors.lastname: Zarbakhsh
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007492:Iran; D004364:Pharmaceutical Preparations / Q000592:standards*; D014944:World Health Organization
chemical_list: D004364:Pharmaceutical Preparations