The European Medicines Agency's human medicines database contains 2,313 product entries. Of those, 1,556 are currently authorized — 67.2% of the total. Antineoplastic and immunomodulating agents account for 29% of all entries. And 355 previously authorized products have been withdrawn from the market, with oncology, HIV, and cardiovascular drugs leading the withdrawal list.
This analysis is drawn from the EMA medicines database, which tracks all human medicinal products that have undergone the centralized marketing authorization procedure. Each entry represents a distinct EMA product number — meaning a single active substance may appear multiple times if it is authorized under different brand names by different marketing authorization holders. The 2,313 records include products across all lifecycle stages: currently authorized, withdrawn, refused, lapsed, and under review.
Status at a glance
| Status | Count | Share |
|---|---|---|
| Authorized | 1,556 | 67.2% |
| Withdrawn | 355 | 15.3% |
| Application withdrawn | 265 | 11.5% |
| Refused | 61 | 2.6% |
| Lapsed | 27 | 1.2% |
| Opinion (under review) | 20 | 0.9% |
| Expired | 17 | 0.7% |
| Revoked | 8 | 0.3% |
| Other | 4 | 0.2% |
Two-thirds of all products that have entered the EMA centralized procedure are currently authorized. The 15.3% withdrawal rate (355 products) represents products that were authorized at some point but have since been voluntarily or involuntarily removed from the market. The 2.6% refusal rate (61 products) represents applications that did not meet the EMA's benefit-risk standards.
The 265 "application withdrawn" entries represent sponsors who pulled their applications before the CHMP issued an opinion — often after receiving a negative signal during the review process. These pre-decision withdrawals typically indicate that the sponsor recognized the application would not meet the evidentiary threshold.
Therapeutic areas: oncology dominates
| Therapeutic area (MeSH) | Products |
|---|---|
| Breast neoplasms | 88 |
| Diabetes mellitus, type 2 | 87 |
| Non-small-cell lung carcinoma | 83 |
| HIV infections | 79 |
| Rheumatoid arthritis | 63 |
| Psoriatic arthritis | 56 |
| Psoriasis | 55 |
| Immunization | 54 |
| Diabetes mellitus (general) | 51 |
| Hypertension | 49 |
| Myocardial infarction | 47 |
| Multiple myeloma | 46 |
| Cancer (general) | 43 |
| Crohn disease | 42 |
Breast cancer (88 products), type 2 diabetes (87), and NSCLC (83) are the three most common therapeutic areas — a concentration that reflects both disease prevalence and commercial opportunity. Oncology products, when aggregated across all cancer types, represent the largest single therapeutic cluster. HIV (79 products) retains a substantial footprint, reflecting decades of antiretroviral development and the multiple combination products that have been authorized.
Immunization (54 products) includes both routine vaccines and the COVID-19 vaccine authorizations that accelerated through the EMA's rolling review procedure.
ATC pharmacotherapeutic groups
| ATC level 1 | Products | Share |
|---|---|---|
| L – Antineoplastic & immunomodulating | 662 | 28.6% |
| J – Anti-infectives for systemic use | 298 | 12.9% |
| A – Alimentary tract & metabolism | 236 | 10.2% |
| N – Nervous system | 225 | 9.7% |
| B – Blood & blood forming organs | 163 | 7.0% |
| C – Cardiovascular system | 116 | 5.0% |
| M – Musculo-skeletal system | 97 | 4.2% |
| V – Various | 95 | 4.1% |
| R – Respiratory system | 78 | 3.4% |
| S – Sensory organs | 69 | 3.0% |
| G – Genito-urinary & sex hormones | 64 | 2.8% |
| H – Systemic hormonal preparations | 54 | 2.3% |
| D – Dermatologicals | 24 | 1.0% |
| P – Antiparasitic products | 5 | 0.2% |
The ATC Level 1 distribution confirms oncology's dominance. Group L (antineoplastic and immunomodulating agents) at 662 products is more than double the next-largest group (anti-infectives at 298). Within Group L, the two largest subgroups are antineoplastic agents (L01, 395 products) and immunosuppressants (L04, 183 products) — the latter driven by the wave of monoclonal antibody biosimilars for autoimmune diseases.
Anti-infectives (J) at 298 products include antivirals (J05, 117 products) and antibacterials (J01, 38 products), reflecting both the HIV treatment landscape and antibiotic development incentives.
Pharmacotherapeutic concentration
| Pharmacotherapeutic group | Products |
|---|---|
| Antineoplastic agents | 371 |
| Immunosuppressants | 168 |
| Drugs used in diabetes | 122 |
| Antivirals for systemic use | 114 |
| Vaccines | 80 |
| Antithrombotic agents | 73 |
| Ophthalmologicals | 62 |
| Drugs for bone diseases | 60 |
| Immunostimulants | 58 |
| Obstructive airway disease drugs | 49 |
The pharmacotherapeutic group breakdown mirrors the ATC analysis but highlights specific product clusters. Vaccines (80 products) represent a substantial standalone category that includes both pandemic-response products and routine immunizations.
The most-authorized active substances
| Active substance | Products | Therapeutic area |
|---|---|---|
| Denosumab | 29 | Bone metabolism, oncology |
| Pegfilgrastim | 23 | Neutropenia |
| Metformin HCl | 21 | Diabetes |
| Emtricitabine | 19 | HIV |
| Hydrochlorothiazide | 19 | Hypertension |
| Insulin human | 19 | Diabetes |
| Adalimumab | 17 | Autoimmune |
| Ustekinumab | 16 | Autoimmune |
| Bevacizumab | 16 | Oncology |
| Clopidogrel | 16 | Cardiovascular |
| Aflibercept | 15 | Ophthalmology |
| Telmisartan | 14 | Hypertension |
| Trastuzumab | 13 | Oncology |
| Formoterol fumarate | 13 | Respiratory |
| Teriparatide | 12 | Bone metabolism |
Denosumab leads with 29 product entries — reflecting the proliferation of biosimilar entries for both the Prolia (osteoporosis) and Xgeva (oncology) indications. Pegfilgrastim (23 products) shows similar biosimilar-driven multiplication. The biosimilar effect is visible across the table: adalimumab (17 products), ustekinumab (16), bevacizumab (16), aflibercept (15), and trastuzumab (13) all have multiple authorized presentations from different marketing authorization holders.
Withdrawn products: what leaves the market
| Therapeutic area (MeSH) | Withdrawn products |
|---|---|
| Immunization | 21 |
| Myocardial infarction | 19 |
| Non-small-cell lung carcinoma | 19 |
| HIV infections | 17 |
| Influenza | 15 |
| Hypertension | 15 |
| Type 2 diabetes mellitus | 14 |
| Hepatitis C, chronic | 14 |
| Peripheral vascular diseases | 14 |
| Stroke | 12 |
The withdrawal profile differs from the authorization profile in important ways. Immunization leads withdrawals (21 products) despite ranking only eighth in total products. This reflects the volatility of the vaccine market, where seasonal reformulation requirements and post-pandemic overcapacity have led to product discontinuations. The 15 influenza withdrawals are primarily seasonal vaccine presentations that were superseded by newer formulations.
Hepatitis C (14 withdrawals) is a striking concentration. The introduction of direct-acting antivirals (DAAs) — sofosbuvir/ledipasvir, sofosbuvir/velpatasvir — rendered earlier interferon-based regimens obsolete, leading to voluntary withdrawals of products that were no longer commercially viable or medically appropriate. This therapeutic area represents one of the clearest examples of innovation-driven market displacement in the EMA database.
Myocardial infarction and cardiovascular products show high withdrawal counts, driven by generic market exit (older products replaced by newer agents) and portfolio rationalization by marketing authorization holders.
Refused products: where the evidence fell short
| Therapeutic area | Refused |
|---|---|
| Amyotrophic lateral sclerosis | 3 |
| Neuroblastoma | 2 |
| Duchenne muscular dystrophy | 2 |
| Acute myeloid leukemia | 2 |
| Breast neoplasms | 2 |
| Non-Hodgkin lymphoma | 2 |
| Alzheimer disease | 2 |
| Fibromyalgia | 2 |
| Crohn disease | 2 |
| Major depressive disorder | 2 |
ALS (3 refusals) and Duchenne muscular dystrophy (2 refusals) top the refusal list — both rare diseases where the evidentiary threshold for benefit-risk is particularly difficult to meet in small patient populations. Alzheimer's disease (2 refusals) reflects the well-documented challenges of demonstrating cognitive benefit in pivotal trials. These refusal patterns are consistent with the broader observation that rare-disease and CNS applications face higher regulatory barriers at the EMA than in other therapeutic areas.
The biosimilar footprint
While the EMA dataset does not include an explicit biosimilar flag, the active substance concentration analysis reveals the biosimilar effect. Substances with the highest product counts — denosumab (29), pegfilgrastim (23), adalimumab (17), ustekinumab (16), bevacizumab (16), trastuzumab (13) — are all reference biologics with authorized biosimilar competitions. The EMA approved a record 28 biosimilars in 2024, and 21 more had received positive CHMP opinions or authorizations through mid-2025.
The biosimilar authorization rate has accelerated sharply. As of July 2025, the EMA had authorized approximately 119 biosimilars (excluding withdrawn products), compared to 72 FDA-approved biosimilars in the United States. Europe's earlier start and higher cumulative approval count reflect the EU's biosimilar pathway having been operational since 2006, predating the US 351(k) pathway by six years.
What this means for regulatory strategy and market access teams
1. Oncology is both the opportunity and the battleground. With 662 products in ATC Group L and 28 oncology-specific CHMP recommendations in 2024, the EU oncology market is the most competitive therapeutic area for new entrants. Payer negotiations and HTA submissions should anticipate biosimilar and competitor density in any target indication.
2. Biosimilar density creates portfolio complexity. Denosumab's 29 product entries — from both originator and biosimilar applicants — illustrate the licensing and market-access complexity that biosimilar proliferation creates. Each product requires separate pricing and reimbursement negotiations, and the market share dynamics shift rapidly as new biosimilars enter.
3. Withdrawal patterns reveal obsolescence risk. The hepatitis C withdrawal cluster (14 products) shows how therapeutic innovation can rapidly render an entire product category obsolete. Pipeline planners should assess whether their therapeutic area faces similar disruption risk from upcoming modalities (cell and gene therapies, RNA-based drugs, ADCs).
4. Rare-disease refusals signal evidentiary expectations. ALS, Duchenne muscular dystrophy, and other rare diseases account for a disproportionate share of EMA refusals. Sponsors planning rare-disease centralized applications should consider PRIME designation, adaptive pathways, and earlier CHMP scientific advice to strengthen their benefit-risk case.
5. The EMA–FDA divergence is narrowing. While the EMA maintains a higher cumulative biosimilar count (119 vs. 72), the FDA has accelerated its approval pace, with 18 biosimilar approvals in 2024. Cross-reference strategies that leverage EMA approvals for US 351(k) submissions — and vice versa — should account for the converging regulatory timelines.
Sources
- European Medicines Agency (EMA) medicines / EPAR data, extract dated 2026-06-10; analysis by PharmaDossier, run date 2026-06-10. Human medicines dataset filtered by Category = Human. Therapeutic areas mapped to MeSH descriptors. https://www.ema.europa.eu/en/medicines
- EMA, "Human medicines in 2024." https://www.ema.europa.eu/en/news/human-medicines-2024
- GaBI Online, "EMA Approved a Record 28 Biosimilars in 2024." https://gabionline.net/reports/ema-approved-a-record-28-biosimilars-in-2024
- Biosimilars IP Law Bulletin, "How the U.S. Compares to Europe on Biosimilar Approvals." https://www.biosimilarsip.com/2025/05/05/how-the-u-s-compares-to-europe-on-biosimilar-approvals-and-products-in-the-pipeline-updated-may-2-2025
- Alira Health, "Biosimilars Market 2025." https://alirahealth.com/biosimilars-market-2025-market-size-growth-drivers-regional-dynamics
- FDA, "Biosimilar Product Information." https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
