Biologics and biosimilars Medicines Approved in the EU (EMA)

• 35medicines authorised in the EU (authorised now)

Each number has its full source under its own list below.

• 17Nov2025

  Usgena

  Active substance: ustekinumab

  EMEA/H/C/006667
• 19Jun2025

  Tepezza

  Active substance: teprotumumab

  EMEA/H/C/006396
• 23Apr2025

  Lynozyfic

  Active substance: linvoseltamab

  EMEA/H/C/006370
• 12Feb2025

  Zefylti

  Active substance: filgrastim

  EMEA/H/C/006400
• 12Dec2024

  Imuldosa

  Active substance: ustekinumab

  EMEA/H/C/006221
• 25Sep2024

  Fymskina

  Active substance: ustekinumab

  EMEA/H/C/005805
• 24Jul2024

  Cejemly

  Active substance: sugemalimab

  EMEA/H/C/006088
• 20Jun2024

  Wezenla

  Active substance: ustekinumab

  EMEA/H/C/006132
• 16Feb2024

  Velsipity

  Active substance: Etrasimod arginine

  EMEA/H/C/006007
• 26May2023

  Omvoh

  Active substance: mirikizumab

  EMEA/H/C/005122
• 17Aug2022

  Pepaxti

  Active substance: Melphalan flufenamide hydrochloride

  EMEA/H/C/005681
• 20Jun2022

  Tabrecta

  Active substance: capmatinib dihydrochloride monohydrate

  EMEA/H/C/004845
• 3Jun2022

  Lunsumio

  Active substance: mosunetuzumab

  EMEA/H/C/005680
• 31May2022

  Zolsketil pegylated liposomal

  Active substance: doxorubicin hydrochloride, liposomal

  EMEA/H/C/005320
• 16Feb2022

  Tepmetko

  Active substance: tepotinib hydrochloride monohydrate

  EMEA/H/C/005524

Source: European Medicines Agency, Centrally authorised human medicines (EPAR), authorised now. Retrieved 12 Nov 2026.

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