The List of Selected Biological Medicinal Products

Updated 03 October 2025

The following list of selected biological medicinal products is continuously updated by the Danish Medicines Agency, and all new biological medicinal products are added to the list as they enter the market.

Focus on Reports of Suspected Side Effects

Since the Danish Medicines Agency monitors side effects of all approved and marketed medicines in Denmark, our monitoring of selected biological medicinal products aims to increase the likelihood of detecting any batch-related side effect issues.

All reports of suspected side effects related to medicines on this list should, as far as possible, include information about the medicines product name and batch number. The requirements for the contents of a side effect report are outlined in § 7 of the Executive Order on Reporting of Adverse Reactions to Medicinal Products etc. (No. 1823 of December 15, 2015).

All reports concerning biological medicinal products, including biosimilar products, are quality-assured upon receipt. If a report concerning a medicine on this list lacks the product name and batch number, the Danish Medicines Agency will, where possible, obtain this information.

All medicines on this list also appear on the list of medicines with stricter reporting obligations. This means that doctors, dentists, and midwives are required to report all suspected side effects of the given medicine.

Continuous Evaluation of the List

The Danish Medicines Agency regularly assesses whether medicines should remain on the list. If no safety signals are observed or very few side effect reports are received over time, despite a certain usage level, medicines are removed from the list (though not earlier than two years after the first marketing date).

Older biological medicinal products may also be added to the list if it is deemed necessary to collect more data in order to assess patient safety.

Stay Updated on Revisions

You can stay updated on revisions to the list of selected biological medicinal products. On the homepage of lmst.dk, under News, you can subscribe to the category Notifications about medicines to healthcare professionals”.

List of Selected Biological Medicinal Products

Below is the list of selected biological medicinal products – sorted alphabetically by product name. The list was last updated 7 March 2025.

Reminder: Healthcare professionals are required to record the medicine product name and batch number when reporting suspected side effects related to medicines on this list.

Product Name

Active Substance

Date of Marketing

Abevmy Bevacizumab 15-04-2024
ADZYNMA Apadamtase alfa 03-02-2025
ALTUVOCT Efanesoctocog alfa 02-09-2024
Atgam Anti t-lymphocyt immunoglobulin 14-11-2022
BEKEMV Eculizumab 24-07-2023
Binocrit Epoetin Alfa 05-02-2024
Briumvi Ublituximab 17-03-2025
CARVYKTI Ciltacabtagen autoleucel 23-12-2024
Casgevy Exagamglogene autotemcel 17-03-2025
Columvi Glofitamab 18-09-2023
Ebglyss Lebrikizumab 05-02-2024
Elfabrio Pegunigalsidase alfa 07-08-2023
ELREXFIO Elranatamab 01-04-2024
Enjaymo Sutimlimab 12-06-2023
Enrylaze Crisantaspase 11-12-2023
Erwinase Crisantaspase 22-01-2024
Eylea Aflibercept 19-02-2024
Hemgenix Etranacogendezaparvovec 10-06-2024
Hemlibra Emicizumab 09-04-2018
IMJUDO Tremelimumab 01-05-2023
Jemperli Dostarlimab 13-12-2021
IMULDOSA Ustekinumab 17-02-2025
KIMMTRAK Tebentafusp 20-02-2023
Lonquex Lipegfilgrastim 30-10-2023
Luxturna Voretigen-neparvovec 10-02-2020
Metalyse TENECTEPLASE 15-04-2024
Movymia Teriparatid 09-09-2019
Nexviadyme Avalglucosidase-alfa 05-09-2022
Omvoh Mirikizumab 16-10-2023
PADCEV Enfortumab vedotin 27-06-2022
Pegasys Peginterferon Alfa-2a 18-03-2024
Piasky Crovalimab 20-01-2025
Pombiliti Cipaglucosidase Alfa 18-03-2024
Prolastina Alfa-1 proteinaseinhibitor, humant 08-01-2024
Pyzchiva Ustekinumab 28-10-2024
Ranivisio Ranibizumab 21-08-2023
Relfydess Clostridium botulinum, type A toxin 28-04-2025
Sarclisa Isatuximab 10-08-2020
Skyrizi Risankizumab 11-12-2023
Sogroya Somapacitan 24-07-2023
Sondelbay Teriparatid 31-10-2022
Spevigo Spesolimab 17-04-2023
STEQEYMA Ustekinumab 14-10-2024
TALVEY Talquetamab 13-11-2023
TECVAYLI Teclistamab 14-11-2022
Tepkinly Epcoritamab 13-11-2023
Tevimbra Tislelizumab 09-06-2025
Tezspire Tezepelumab 28-11-2022
Tremfya Guselkumab 23-06-2025
Tyruko Natalizumab 03-02-2025
Ultomiris Ravulizumab 28-12-2020
Uplizna Inebilizumab 06-05-2025
Uzpruvo Ustekinumab 22-07-2024
Vabysmo Faricimab 12-12-2022
VEGZELMA Bevacizumab 17-03-2025
Voraxaze Glucarpidase 31-10-2022
VYEPTI Eptinezumab 05-09-2022
Vyloy Zolbetuximab 25-11-2024
WEZENLA Ustekinumab 17-02-2025
Winrevair Sotatercept 28-10-2024
Xenpozyme Olipudase alfa 28-04-2025
Xgeva Denosumab 27-05-2024
Yuflyma Adalimumab 05-02-2024