A generic is a medicinal product that refers to an already authorized reference medicinal product and whose active substance composition, pharmaceutical form and bioequivalence fulfill the legal requirements. Under the conditions of Article 10 of Directive 2001\/83\/EC, the existing pre-clinical and clinical findings on the reference medicinal product can be used for the marketing authorization application. Generics therefore combine an independent proof of quality with an abbreviated regulatory pathway for safety and efficacy.<\/p>\n
Article 10(2)(b) of Directive 2001\/83\/EC defines a generic medicinal product as a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The reference medicinal product is a medicinal product authorized under Article 6, based on a complete dossier.<\/p>\n
The application according to Article 10(1) is an abbreviated application. The applicant is not required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product. However, the use of this regulatory reference affects neither the independent responsibility for quality nor the requirements for product information, manufacturing and pharmacovigilance.<\/p>\n
The product information of a generic must match that of the reference medicinal product in the relevant points, unless patent rights or regulatory justified exceptions stand in the way. After authorization, the pharmacovigilance obligations apply independently to the respective generic. Suspected adverse reactions, signals, variation notifications and the maintenance of the authorization dossier therefore belong to the ongoing product life cycle.<\/p>\n
Bioequivalence is intended to show that the generic and the reference medicinal product are equivalent in terms of biopharmaceutical quality, so that reference can be made to the pre-clinical and clinical data of the reference product. The EMA guideline on the investigation of bioequivalence describes the requirements for the planning, conduct and evaluation of studies for this purpose, in particular for immediate-release dosage forms with systemic action.<\/p>\n
Depending on the product, bioequivalence data are generally collected through in vivo bioavailability studies. The study design must comprehensibly cover the reference product, the formulation, the sampling, the bioanalytical method and the statistical analysis. The choice of an unsuitable reference product, inadequately justified deviations from the protocol or gaps in bioanalysis can lead to regulatory questions.<\/p>\n
Bioequivalence is not a mere exchange of batch analyses. It complements the pharmaceutical development and the CMC part of the dossier. For certain medicinal products or dosage forms, product-specific guidelines, alternative approaches or additional data may be required; whether a biowaiver is possible depends on the criteria applicable for this.<\/p>\n
Irrespective of this, the application must contain a complete quality dossier for the applicant’s own finished product and the manufacturing process. Starting materials, specifications, manufacturing validation and stability are evaluated for the specific generic. Differences in excipients or manufacturing can be permissible, but must be properly justified in the dossier.<\/p>\n
A biosimilar is not a generic within the meaning of Article 10(2)(b). For biological medicinal products, differences can exist due to the nature of the raw material or the manufacturing process. Article 10(4) therefore requires additional pre-clinical or clinical data to justify the type and amount of necessary comparative data. The proof follows an independent, step-wise comparability exercise.<\/p>\n
Hybrid authorization according to Article 10(3) is also to be distinguished from the generic. It comes into consideration if the strict generic definition is not met or bioequivalence studies are not sufficient, for example in the event of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration. Then the results of the appropriate pre-clinical tests or clinical trials must be provided; the application is therefore not supported solely by the usual generic proof.<\/p>\n
A parallel import is also not a generic. It concerns the marketing of an already authorized medicinal product that is obtained from another Member State, and not the development of a new product based on bioequivalence according to Article 10. The parallel import therefore replaces neither a generic dossier nor the product-specific proof of quality and bioequivalence of a generic.<\/p>\n
For generics, clinical development often focuses on the regulatory robust planning and conduct of bioequivalence studies. Clinical operations must coordinate suitable study centers, recruitment, dosing, sample logistics and the timely recording of safety data in such a way that protocol and bioanalysis match. Regulatory affairs requires a clear derivation of the reference medicinal product and a consistent presentation of the data in the marketing authorization dossier.<\/p>\n
Full-service CROs such as Mediconomics support protocol development, the selection and management of study sites, monitoring, sample and bioanalytical logistics, data management, biostatistics and pharmacovigilance. These services help to comprehensibly bring together bioequivalence data and the associated documentation for regulatory submission.<\/p>\n
Is a generic identical to the original medicinal product?<\/strong><\/p>\n A generic must demonstrate the legally required active substance composition, pharmaceutical form and bioequivalence to the reference medicinal product. However, it can differ for example in excipients, manufacturing process, name or packaging. For authorization, the applicant’s own product is evaluated independently in terms of quality.<\/p>\n Why do not all clinical trials have to be repeated for a generic?<\/strong><\/p>\n Article 10(1) of Directive 2001\/83\/EC allows under its conditions to refer to the results of the reference medicinal product. For this, the applicant must demonstrate among other things that their product is a generic in the legal sense and that bioequivalence has been adequately proven.<\/p>\n When is a pure generic application not sufficient?<\/strong><\/p>\n If the requirements for a generic are not met or bioequivalence studies are not sufficient, another authorization pathway may be required. Article 10(3) regulates the hybrid application for this; for biological medicinal products, Article 10(4) is particularly relevant.<\/p>\n A generic is a medicinal product that refers to an already authorized reference medicinal product and whose active substance composition, pharmaceutical form and bioequivalence fulfill the legal requirements. Under the conditions of Article 10 of Directive 2001\/83\/EC, the existing pre-clinical and clinical findings on the reference medicinal product can be used for the marketing authorization […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6755","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6755","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6755\/revisions"}],"predecessor-version":[{"id":7412,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6755\/revisions\/7412"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6755"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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