title: Why EMA should provide clearer guidance on the authorization of NBCDs in generic and hybrid applications.
authors.affiliation: a CESAV, Centre for Health Economics , IRCCS Institute for Pharmacological Research 'Mario Negri' , Ranica , Italy.
authors.forename: Livio
authors.initials: L
authors.lastname: Garattini
authors.affiliation: a CESAV, Centre for Health Economics , IRCCS Institute for Pharmacological Research 'Mario Negri' , Ranica , Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Padula
mesh_terms: D017277:Drug Approval; D016568:Drugs, Generic / Q000592:standards*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*
chemical_list: D016568:Drugs, Generic; D004364:Pharmaceutical Preparations
keywords: EMA; Europe; biosimilar; generic; non biological complex drug; procedure