Drug Development & Regulation

Generic Drug

TRJenerik İlaç
Also known as:Generic medicine · Generic medicinal product · Multisource drug

A medicinal product with the same qualitative and quantitative composition in active substance(s) and the same pharmaceutical form as a reference product, whose bioequivalence with that product has been demonstrated.

In depth

Generic applications are abridged: once data protection of the reference product has expired, they rely on its nonclinical and clinical data and must demonstrate pharmaceutical quality and bioequivalence. Different salts, esters or isomers of the active substance are generally regarded as the same active substance unless they differ significantly in safety or efficacy.

Generics may differ from the reference in excipients, shape, color and packaging, and are marketed under the INN or a new trade name. This pathway applies to chemically synthesized drugs; copies of biological medicines follow the biosimilar pathway.

Clinical pearl

Differences in appearance between products can cause confusion or duplicate dosing, and some excipients (e.g., lactose, azo colorants) matter for intolerant patients; patients should be counseled when products are switched.

TRIn Turkish

Jenerik İlaç

Referans ürünle aynı etkin madde(ler)i aynı nitel ve nicel bileşimde içeren, aynı farmasötik şekle sahip ve referans ürünle biyoeşdeğerliği kanıtlanmış tıbbi üründür.

Jenerik başvuruları kısaltılmış başvurulardır: referans ürünün veri koruma süresi dolduktan sonra onun klinik dışı ve klinik verilerine dayanır; farmasötik kalitenin ve biyoeşdeğerliğin gösterilmesi gerekir. Etkin maddenin farklı tuzları, esterleri veya izomerleri, güvenlilik ya da etkinlik açısından belirgin farklılık göstermedikçe genellikle aynı etkin madde kabul edilir.

Jenerik ürünler yardımcı maddeler, şekil, renk ve ambalaj bakımından referans üründen farklı olabilir ve INN ya da yeni bir ticari adla piyasaya sunulur. Bu yol kimyasal olarak sentezlenen ilaçlar için geçerlidir; biyolojik ilaçların kopyaları biyobenzer yolunu izler.

Ürünler arasındaki görünüm farklılıkları karışıklığa ya da mükerrer doz alımına yol açabilir; bazı yardımcı maddeler (örneğin laktoz, azo boyalar) duyarlı hastalarda önem taşır. Ürün değiştirildiğinde hastaya danışmanlık verilmelidir.

Diğer adları:Eşdeğer ilaç · Jenerik ürün
Updated 24.09.2026 1 views Educational reference — verify against current sources before clinical use.

Read next

BioequivalenceBiyoeşdeğerlik

The absence of a significant difference in the rate and extent of absorption of the active substance when two pharmaceutically equivalent or alternative products are given at the same molar dose under similar conditions.

 Reference ProductReferans Ürün

The originally authorized medicinal product, approved on the basis of a complete dossier, against which generic or biosimilar versions are compared to demonstrate equivalence or similarity.

 BiosimilarBiyobenzer

A biological medicine highly similar to an already authorized reference biological product, with no clinically meaningful differences in quality, safety or efficacy, as shown by a comprehensive comparability exercise.

 International Nonproprietary NameUluslararası Mülkiyete Konu Olmayan İsim

A unique, globally recognized generic name assigned by the World Health Organization to a pharmaceutical substance, which is public property and cannot be registered as a trademark.

 ExcipientYardımcı Madde

Any constituent of a medicinal product other than the active substance, added to enable manufacture, maintain stability, control release, improve acceptability or aid administration.

 Narrow Therapeutic Index DrugDar Terapötik İndeksli İlaç

A drug for which small differences in dose or blood concentration may lead to serious therapeutic failure or serious adverse drug reactions.