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TL;DRBiosimilar is a biological medicine that is highly similar to an already authorised biological medicine, called the reference medicine, with no clinically meaningful differences in safety, quality or efficacy. The European Medicines Agency stresses one point above all: a biosimilar is not a generic.
That distinction is not a technicality, it follows from the nature of the molecule. A generic is a chemically synthesised small molecule that can be reproduced identically, so it is treated as the same substance as the original. A biological medicine is a large, complex protein produced in living cells. That production carries an inherent, unavoidable variability, so an exact copy is not possible, not even for the originator between two of its own batches. A biosimilar is therefore developed to be highly similar, not identical, and it must be demonstrated to be so through a dedicated comparison.
Teams new to the topic often assume a biosimilar relates to a biological the way a generic relates to a chemical drug. It does not, and the difference is worth being precise about, because it changes how the medicine is approved and how it is handled at the pharmacy.
| Aspect | Generic | Biosimilar |
|---|---|---|
| Reference | Chemical originator medicine | Biological reference medicine |
| Molecule | Small, chemically synthesised | Large, complex protein |
| Production | Chemical synthesis, reproducible | Living cells, inherent variability |
| Standard of the copy | Identical active substance | Highly similar, no clinically meaningful difference |
| Approval basis | Bioequivalence | Comparability exercise |
The comparability exercise is the stepwise, head to head demonstration that a biosimilar and its reference medicine are highly similar. It starts with detailed analytical and structural characterisation of the molecule, moves to functional and non clinical studies, and ends with clinical data. Because the benefit and risk of the reference medicine are already established, the goal is not to prove the biosimilar works from scratch. The goal is to show there are no clinically meaningful differences in safety, quality and efficacy. This is why a biosimilar dossier looks different from an originator dossier: the analytical comparison carries the weight, rather than a repeat of the full clinical programme.
The EU authorised the world's first biosimilar in 2006. Since then a large body of use has accumulated, and the European regulators have noted safety data covering more than a million patient treatment years. That evidence base is what underpins their current position on interchangeability.
These two questions are constantly merged, yet they have different answers and different owners.
Interchangeability is a scientific and regulatory judgement, and at EU level it is settled. In a joint statement on 19 September 2022, the EMA and the Heads of Medicines Agencies (HMA) confirmed that biosimilars approved in the EU are interchangeable with their reference medicine and with each other, meaning one can be exchanged for another with the same clinical effect. Crucially, that statement does not itself authorise automatic substitution at the pharmacy counter. It explicitly leaves substitution to the individual Member States.
Substitution at pharmacy level is national law. In Germany it follows the Arzneimittel-Richtlinie of the G-BA, under the mandate in §129 SGB V, and it arrived in stages.
So the honest summary for Germany in 2026 is this: interchangeability is scientifically confirmed EU wide, and automatic pharmacy substitution of finished biosimilars is now permitted, but only inside the tightly defined conditions of §40c.
Which biosimilar a patient actually receives is often steered by cost containment rather than by the prescription alone. Discount contracts between manufacturers and statutory health insurers, and Open House tenders, determine the preferred product for a given health insurer. Once the substitution conditions are met, the pharmacy dispenses accordingly, and the reimbursement side is governed by the Hilfstaxe. This is the point where the clinical concept of interchangeability meets the commercial reality of tendering, and it is why professionals need the biosimilar grouping and the substitution relevant attributes in one place.
On pharmazie.com the biosimilar relationship is carried in the article comparison block of each article, next to the clinical and regulatory context.
One honest limitation: the platform shows the biosimilar grouping and the substitution relevant article attributes, but the clinical decision to substitute a specific patient's biologic stays with the pharmacist and the prescriber under §40c. The data supports that decision, it does not replace it.
