Advanced Therapy Medicinal Products
ATMPs cover several different types of treatments. Some work with genes, others with cells or tissue. What they have in common is that they are based on biological material and can be used to change, repair, or replace functions in the body that are not working as they should.
What is ATMP?
ATMP stands for Advanced Therapy Medicinal Products. In Danish, we often talk about advanced therapies. These are medicines based on genes, cells, or tissue, and they can be used to change, repair, or replace biological functions in the body.
That is why ATMPs differ from many traditional medicines. They do not only work by affecting the body from the outside, but in some cases can intervene more directly in the very cause of the disease.
ATMPs are used especially for serious diseases where there is a need for new treatment options—for example, certain types of cancer, rare inherited diseases, or diseases where cells or tissue are damaged.
ATMPs are divided into three types
When we get sick, it is sometimes because something fundamental in the body is not working as it should. This can be in our genes, cells, or tissue. ATMPs are a new type of medicines that take their starting point exactly there.
A term from the EU
Advanced Therapy Medicinal Products (ATMP) are the EU’s common term for advanced biological medicines based on genes, cells, or tissue. The concept was introduced into EU legislation (Regulation (EC) No 1394/2007) because these therapies did not fit into the existing rules for traditional medicines.
Therefore, a common European framework was created that both protects patients and makes it possible to develop and use these new treatments.
Denmark is strongly positioned in the ATMP area
Denmark has a strong foundation for the development and implementation of advanced therapies. We combine highly specialized clinical environments, unique health data, and a well-functioning life science sector. This creates good conditions for bringing new treatments from research to patients.
Strong professional environments
Denmark has a highly specialized healthcare system and strong professional environments at hospitals and universities that are active in international collaborations and, in several areas, leading within Europe. This means that new advanced treatments can be developed and tested close to the patients who can benefit from them.
Data and follow-up
Denmark has solid experience with clinical trials and research carried out close to everyday patient care. At the same time, our health registries and CPR system make it possible to follow patients over the long term and document whether the treatments work and are safe.
Collaboration across sectors
Denmark has a strong life science sector with experience in developing, producing, and implementing ATMPs. At the same time, we have a long tradition of collaboration between hospitals, researchers, authorities, and companies. This provides good frameworks for developing, producing, and putting ATMPs into use.
From European approval to treatment in Denmark
Before a new medicine can be put into use in Denmark, it must first be approved at the European level. This takes place at the European Medicines Agency (EMA), which reviews all documentation on the medicine’s quality, effectiveness, and safety.
If the EMA assesses the medicine positively, the European Commission grants an official authorization to market the medicine. This means that, in principle, it can be used in all EU countries.
In Denmark, it is the Danish Medicines Council (Medicinrådet) that assesses whether the medicine should be used in the Danish healthcare system as standard treatment. The Danish Medicines Council looks, among other things, at:
How well the treatment works
What side effects there are
And whether the price is in line with the effect
The price is negotiated by Amgros with the manufacturer and is included in the assessment of whether the treatment provides value for money. On that basis, the Danish Medicines Council recommends whether the medicine should be used as standard treatment in Denmark.
The Danish healthcare system
The Danish healthcare system is responsible for ensuring good, fast, and safe treatment for all citizens.
Every year, 9 out of 10 Danes are in contact with the healthcare system. This can, for example, be with their general practitioner, at a hospital, with a specialist doctor, or with the dentist.
Denmark spends around DKK 150 billion annually on the healthcare system. Most of it is financed through taxes. This means that, as a citizen, you generally do not pay yourself for seeing a doctor or being treated in a hospital.
The healthcare system is divided between the state, regions, and municipalities. The state sets the rules and has overall responsibility. The regions run the hospitals and provide specialized treatment. Municipalities are responsible for the local healthcare services, including prevention, care, and rehabilitation.
Source: Ministry of Health and Care
A look into the future—here you can see which ATMPs are on the way
A recommendation from the European Medicines Agency (EMA) means that a medicine is assessed as safe and effective at the European level. However, that is not the same as the treatment automatically being put into use in Denmark. In Denmark, it is the Danish Medicines Council (Medicinrådet) that assesses whether hospitals should offer the treatment—among other things based on effectiveness, side effects, and price. Therefore, it may take some time before a medicine is possibly available to patients.
The stated timeframes are estimates and may change.
Adstiladrin | Gene therapy | |||
Which disease? | How does it work? | |||
Bladder cancer (non–muscle-invasive) with carcinoma in situ A type of bladder cancer in which the cancer cells are located in the bladder’s lining and have not grown down into the muscle of the bladder wall. It is normally treated with BCG instillations (a tuberculosis vaccine derivative), but for some patients, BCG no longer works. These patients face the choice between removing the entire bladder or having very few other options. | A harmless virus is used as a "delivery vehicle" to deliver a gene into the bladder lining cells. The gene causes the cells to produce an immune-boosting substance (interferon), which attacks the cancer from within. | |||
Who can get it? | How far along is the process? | |||
Adults with bladder cancer where BCG no longer works Treatment: Instilled into the bladder via a catheter—once every three months | The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the medicine be approved. The European Commission typically makes the final decision within 2–3 months after the recommendation. | |||
Itvisma | Gene therapy | |||
Which disease? | How does it work? | |||
Spinal muscular atrophy (SMA) A rare, inherited disease in which the nerve cells that control the muscles slowly die. This leads to progressively worsening muscle weakness and, in more severe cases, problems with breathing and swallowing. SMA is caused by a defect in the SMN1 gene. Until now, the disease has been one of the most disabling neuromuscular diseases in children. | A harmless virus (AAV9) is used as a "delivery vehicle" to deliver a healthy copy of a missing or defective gene (SMN1) directly into the nerve cells. The cells can then produce the protein they are missing. The treatment is given only once. | |||
Who can get it? | How far along is the process? | |||
Children from age 2, as well as young people and adults with SMA (the gene therapy Zolgensma has so far only been approved for children under 2 years. Treatment: Injection into the spinal canal—once for life. | The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the medicine be approved. The European Commission typically makes the final decision within 2–3 months after the recommendation. |
This overview has been prepared based on Amgros’ Horizon Scanning from April 2026, as well as publicly available information from the EMA and FDA.
Zopapogene imadenovec | Gene therapy (immunotherapy) | |||||
Which disease? | How does it work? | |||||
Recurrent respiratory papillomatosis (RRP) A rare disease in which HPV virus (type 6 or 11) causes recurrent, benign papillomas in the larynx, trachea, and lungs. The papillomas interfere with breathing and require frequent surgeries—some patients must be operated on several times per year. Until now, there has been no medical treatment. | A harmless virus is used to "show" the immune system what the HPV virus proteins look like. This teaches the immune system to recognize and attack the cells infected with HPV. | |||||
Who can get it? | How far along is the process? | |||||
Adults with RRP who need frequent surgeries Treatment: Four injections under the skin over 12 weeks | The EMA has started their first review of the documentation. There are typically 1–2 years until a possible recommendation. The product name and company are published only if the assessment is positive. (The product has already been approved by the FDA in the US under the name Papzimeos in August 2025.) | |||||
TIL-cell therapy (lifileucel) | Cell therapy | |||||
Which disease? | How does it work? | |||||
Advanced melanoma (melanoma) The most serious form of skin cancer that has spread to other parts of the body. It is normally treated with immunotherapy (so-called checkpoint inhibitors) and possibly targeted treatment, but for some patients the disease stops responding and there are limited treatment options left. | The patient’s own immune cells are taken out of the tumor during an operation, expanded in the laboratory into billions of cancer-fighting cells, and then given back to the patient via a blood transfusion. The patient’s own immune system becomes a "tailor-made" treatment. | |||||
Who can get it? | How far along is the process? | |||||
Adults with advanced melanoma, where other treatment no longer works. Treatment: One-time treatment: surgery to retrieve cells, 3–4 weeks of laboratory work, then infusion | The EMA has started their first review. The product name and company are published only if the assessment is positive. (Expected to be Iovance Biotherapeutics’ Amtagvi, which has already been approved in the US and Canada. A previous EU application was withdrawn and has now been resubmitted.) | |||||
Zamtocabtagene autoleucel | CAR-T cell therapy (gene therapy + cell therapy) | |||||
Which disease? | How does it work? | |||||
Expected: cancer in the lymphatic system (B-cell cancer) This CAR-T therapy is aimed at B-cell cancer types. That is, cancer in the white blood cells that produce antibodies. It covers, among other things, certain forms of lymphoma and leukemia. CAR-T is typically used when chemotherapy and other treatment no longer work. | The patient’s own T cells (a type of immune cell) are taken out, genetically modified in the laboratory so they get an artificial "radar" (CAR) that can recognize cancer cells, expanded, and then given back to the patient. The cells then hunt for the cancer cells in the body. | |||||
Who can get it? | How far along is the process? | |||||
Expected: adults with certain B-cell cancer types (specific indication to be determined). Treatment: One-time treatment: blood test to retrieve cells, about 3–4 weeks of laboratory work, then infusion. | The EMA has started their first review. The product name, company, and specific indication are published only if the assessment is positive. There are typically 1–2 years until a possible recommendation. |
This overview has been prepared based on Amgros’ Horizon Scanning from April 2026, as well as publicly available information from the EMA and FDA.
Zopapogene imadenovec | Gene therapy (immunotherapy) | |||||
Which disease? | How does it work? | |||||
Recurrent respiratory papillomatosis (RRP) A rare disease in which HPV virus (type 6 or 11) causes recurrent, benign papillomas in the larynx, trachea, and lungs. The papillomas interfere with breathing and require frequent surgeries—some patients must be operated on several times per year. Until now, there has been no medical treatment. | A harmless virus is used to "show" the immune system what the HPV virus proteins look like. This teaches the immune system to recognize and attack the cells infected with HPV. | |||||
Who can get it? | How far along is the process? | |||||
Adults with RRP who need frequent surgeries Treatment: Four injections under the skin over 12 weeks | The EMA has started their first review of the documentation. There are typically 1–2 years until a possible recommendation. The product name and company are published only if the assessment is positive. (The product has already been approved by the FDA in the US under the name Papzimeos in August 2025.) | |||||
TIL-cell therapy (lifileucel) | Cell therapy | |||||
Which disease? | How does it work? | |||||
Advanced melanoma (melanoma) The most serious form of skin cancer that has spread to other parts of the body. It is normally treated with immunotherapy (so-called checkpoint inhibitors) and possibly targeted treatment, but for some patients the disease stops responding and there are limited treatment options left. | The patient’s own immune cells are taken out of the tumor during an operation, expanded in the laboratory into billions of cancer-fighting cells, and then given back to the patient via a blood transfusion. The patient’s own immune system becomes a "tailor-made" treatment. | |||||
Who can get it? | How far along is the process? | |||||
Adults with advanced melanoma, where other treatment no longer works. Treatment: One-time treatment: surgery to retrieve cells, 3–4 weeks of laboratory work, then infusion | The EMA has started their first review. The product name and company are published only if the assessment is positive. (Expected to be Iovance Biotherapeutics’ Amtagvi, which has already been approved in the US and Canada. A previous EU application was withdrawn and has now been resubmitted.) | |||||
Zamtocabtagene autoleucel | CAR-T cell therapy (gene therapy + cell therapy) | |||||
Which disease? | How does it work? | |||||
Expected: cancer in the lymphatic system (B-cell cancer) This CAR-T therapy is aimed at B-cell cancer types. That is, cancer in the white blood cells that produce antibodies. It covers, among other things, certain forms of lymphoma and leukemia. CAR-T is typically used when chemotherapy and other treatment no longer work. | The patient’s own T cells (a type of immune cell) are taken out, genetically modified in the laboratory so they get an artificial "radar" (CAR) that can recognize cancer cells, expanded, and then given back to the patient. The cells then hunt for the cancer cells in the body. | |||||
Who can get it? | How far along is the process? | |||||
Expected: adults with certain B-cell cancer types (specific indication to be determined). Treatment: One-time treatment: blood test to retrieve cells, about 3–4 weeks of laboratory work, then infusion. | The EMA has started their first review. The product name, company, and specific indication are published only if the assessment is positive. There are typically 1–2 years until a possible recommendation. |
This overview has been prepared based on Amgros’ Horizon Scanning from April 2026, as well as publicly available information from the EMA and FDA.
Advanced therapies are developed and tested here
Denmark has strong environments for advanced therapies—from research in the laboratory to the first clinical studies with patients.
CCIT (Center for Cancer Immune Therapy, Herlev Hospital)
CCIT has a strong national position and an increasingly visible European profile in advanced cancer immunotherapies. The center is characterized by an integrated setup with laboratory research, GMP-compatible cell production, and early clinical testing, which makes it possible to quickly translate knowledge between research and patient treatment and supports the development and clinical translation of next-generation cell therapies, including T cell–based treatments.
Rigshospitalet
Rigshospitalet is Denmark’s leading tertiary hospital and provides advanced treatment and research to a large group of patients receiving advanced therapies, with more than 900 patients treated across 13 departments and 8 specialties. The hospital has solid experience with early clinical trials and clinical implementation of ATMPs and functions both as a sponsor and as a trial site for a number of academic and industry-initiated studies. Research areas include, among other things, CAR T cell therapy in hematology and pediatrics, gene therapy for neurological diseases, and mesenchymal stem cell–based approaches to heart regeneration.
Aalborg University Hospital
Aalborg University Hospital has established a unit for clinical trials that supports both commercial and non-commercial studies and offers GCP monitoring for the non-commercial studies. The unit is part of Aalborg Hospital Science and Innovation Center and provides researchers with a single point of entry for guidance and support for preclinical trials, clinical trials, and innovation. Preclinical research includes, among other things, diagnostics and monitoring in immunotherapy using modern techniques in gene editing, sequencing, and PCR.
Phase IV units (University of Copenhagen/Bispebjerg Hospital, University of Southern Denmark, and Aarhus University)
The University of Copenhagen (Bispebjerg Hospital), the University of Southern Denmark, and Aarhus University have dedicated Phase IV units. Denmark is internationally strong in registry-based medicines research, with documented expertise in pharmacoepidemiology and post-authorization studies for both EMA and FDA.
Novo Nordisk Foundation Center for Stem Cell Medicine (reNEW) (University of Copenhagen)
reNEW has been established with a grant of more than €300 million from the Novo Nordisk Foundation and focuses on stem cell medicine and regenerative therapies, including the social and ethical aspects of ATMP treatments.
CITCO (Centre for Cellular ImmunoTherapy of Haematological Cancer, Odense University Hospital, OUH)
CITCO is among the leading environments in chimeric antigen receptor therapy (CAR) and T cell engineering, with a focus on in vivo delivery of therapeutic products.
Odense University Hospital (OUH)
OUH is one of Denmark’s largest trial sites for CAR T cell therapy and stem cell therapy, with several ongoing protocols, both commercial and the hospital’s own ATMPs. The hospital has access to large cleanroom facilities for clinical production of CAR T and is also planning a vector laboratory. OUH and the University of Southern Denmark are involved in several local and national partnerships with Danish and international medtech and pharma companies, including AstraZeneca (Gothenburg), AlphaLyse (Odense), and Samplix (Birkerød), as well as the Life Science Fyn innovation network.
CeBIL (Center for Advanced Studies in Bioscience Innovation Law, University of Copenhagen)
CeBIL is an interdisciplinary research center focusing on regulation, incentives, and policies for ATMPs, as well as related areas such as medicines for rare diseases, personalized medicine, production of biological medicines, health data, and technology transfer.
CGCT (Center for Gene and Cellular Therapy, Aarhus University, AU)
CGCT focuses on regenerative medicine and immunomodulation with mesenchymal stem cells (MSCs). The center has ongoing clinical ATMP trials in three indications and two additional trials under approval—primarily early-phase trials and investigator-initiated studies—as well as preclinical programs in gene editing of hematopoietic stem cells.
Aarhus University Hospital (AUH)
AUH is strongly committed to the development and translation of advanced therapies, anchored in close collaboration between CGCT and Aarhus University. AUH conducts several investigator-initiated ATMP trials, including CRISPR-based therapies and the development of next-generation CAR T, and contributes internationally through participation in, among others, the European University Hospital Alliance and Join4ATMP.