The List of Selected Biological Medicinal Products

Updated 25 June 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

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

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

KIMMTRAK

Tebentafusp

20-02-2023

Lonquex

Lipegfilgrastim

30-10-2023

Metalyse

TENECTEPLASE

15-04-2024

Nexviadyme

Avalglucosidase-alfa

05-09-2022

Omvoh

Mirikizumab

16-10-2023

Pegasys

Peginterferon Alfa-2a

18-03-2024

Pombiliti

Cipaglucosidase Alfa

18-03-2024

Prolastina

Alfa-1 proteinaseinhibitor, humant

08-01-2024

Ranivisio

Ranibizumab

21-08-2023

Sarclisa

Isatuximab

10-08-2020

Sogroya

Somapacitan

24-07-2023

Sondelbay

Teriparatid

31-10-2022

Spevigo

Spesolimab

17-04-2023

TALVEY

Talquetamab

13-11-2023

TECVAYLI

Teclistamab

14-11-2022

Tepkinly

Epcoritamab

13-11-2023

Tezspire

Tezepelumab

28-11-2022

Ultomiris

Ravulizumab

28-12-2020

Uzpruvo

Ustekinumab

22-07-2024

Vabysmo

Faricimab

12-12-2022

Voraxaze

Glucarpidase

31-10-2022

VYEPTI

Eptinezumab

05-09-2022

Xgeva

Denosumab

27-05-2024

Yuflyma

Adalimumab

05-02-2024