Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Biologicals/biosimilar approved in EU and marketed in SI

Biosimilars approved in the EU published at EMA website – LINK

By clicking on an individual drug, the following information is displayed: overview about the drug in English and Slovenian, authorization details in English, Summary of the main characteristics of the drug – SmPC – in Slovenian and English, Assessment history (EPAR) in English.

Information on the current status of the drug’s presence on the Slovenian market is available on the website of the central drug database: Central drug database 2 – Search (cbz.si)

(Last update: April 2024)

Adalimumab

Refence:

Biosimilars:

Aflibercept

Bevacizumab

Reference:

Biosimilars:

Ekulizumab

Reference:

Biosimilar:

Epoetein

Reference:

Biosimilars:

Others:

Eporatio (epoetin theta)

NeoRecormon (epoetin beta)

Etarnecept

Reference:

Biosimilars:

Filgrastim

Reference:

Biosimilars:

Follitropine alfa

Reference:

Biosimilars:

Puregon (follitropin beta)

Rekovelle (follitropin delta)

Infliximab

Reference

Biosimilars:

Insuline Asparte

Reference:

Biosimilars:

Insulin Degludek

Insulin Degludec/liraglutide

Insulin Degludec/Insulin aspart

Insulin Detemir

Insuline Glargine

Reference:

Biosimilars:

Others:

Suliqua (insulin glargine + lixisenatide)

Insulin Human

Humulin M3

Humulin N

Humulin R

Insilun glulisine

Natalizumab

Pegfilgrastim

Reference:

Biosimilars:

Ranibizumab

Reference:

Biosimilar:

Rituximab

Reference:

Biosimilars:

Somatropine

Reference:

Biosimilars:

Others:

Teriparatide

Reference:

Biosimilars:

Tocilizumab

Reference:

Biosimilar:

Trastuzumab

Reference:

Biosimilars:

Others:

Enhertu (trastuzumab deruxtecan)

Kadcyla (trastuzumab emtansine)

Phesgo (trastuzumab + pertuzumab)

Ustekinumab

Reference:

Biosimilar:

Details

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