title: Regulatory considerations for generic or biosimilar low molecular weight heparins.
abstract: The aim of the present paper is to address the legal aspects, technical requirements and possible conditions of use associated to low molecular weight heparin generics and biosimilars that are arriving to the market in United States and the European Union, respectively. To this end the concept of "similar biological medicinal product" that was coined in 2003 by the pharmaceutical legislation of the European Union is compared to the concept of generic in the United States and the concept of generic in the European Union. This different legal basis determines directly the technical requirements to obtain a marketing authorisation. Therefore, the chemical/biological, non-clinical and clinical requirements to demonstrate therapeutic equivalence are different in these two Regulatory Authorities, FDA and EMA. Consequently, the possible conditions of use are different. In the United States the products approved as generics by the FDA are considered interchangeable to the Reference Listed Drug. In contrast, the EMA legislation only deals with the approvability or prescribability of the medicines and it is a national / regional decision of the member States to consider these biosimilar products as interchangeable or not.
authors.affiliation: Division de Farmacologia y Evaluacion Clinica, Subdirección General de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, C/ Campezo 1. Edificio 8, Planta 2 Oeste, E-28022 Madrid, Spain.
authors.forename: Alfredo
authors.initials: A
authors.lastname: García-Arieta
authors.forename: Antonio
authors.initials: A
authors.lastname: Blázquez
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000493:pharmacokinetics; D005062:European Union; D006495:Heparin, Low-Molecular-Weight / Q000493:pharmacokinetics; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D016568:Drugs, Generic; D006495:Heparin, Low-Molecular-Weight