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TL;DRA generic medicine, in German Generikum, is a medicine that contains the same active substance in the same quantity and the same pharmaceutical form as an already authorised originator, the reference medicinal product, and whose bioequivalence with that reference has been demonstrated by appropriate bioavailability studies. It is authorised only after the originator's patent and regulatory protection have expired.
The defining feature of a generic is not the molecule, which is identical to the originator, but the route by which it reaches the market. Under Article 10(1) of Directive 2001/83/EC, transposed into German law as §24b of the Arzneimittelgesetz (AMG), the applicant does not repeat the full preclinical and clinical programme. Instead the application refers to the dossier of the reference medicinal product, once that product has been authorised in the Union for not less than eight years. This abridged route removes the largest cost in drug development, which is why a generic can be offered well below the originator's price.
The word abridged is precise: the generic applicant still has to prove pharmaceutical quality and manufacturing to the same standard, and still has to show bioequivalence. What it does not have to do is rerun the full efficacy and safety programme, because the safety and efficacy of the active substance are already established through the originator's dossier and years of use. The generic is therefore not a lesser medicine, it is the same substance authorised on a shorter, evidence-bridging path.
Bioequivalence is the scientific basis on which a generic is approved. The EMA describes it plainly: two medicines are bioequivalent when they release the same active ingredient into the body at the same rate and to the same extent under similar conditions. If that is shown, the clinical evidence of the originator carries over, and the generic is treated as therapeutically equivalent. A medicine qualifies as a generic under Article 10(1) only when all of the following hold.
Two comparisons come up constantly, and they are not the same comparison. Against the originator the difference is the authorisation route and the price, not the substance. The table sets that out.
| Aspect | Generic medicine | Originalpräparat (originator) |
|---|---|---|
| Authorisation basis | Abridged application, Article 10, referencing the reference dossier | Full dossier, Article 8(3), own preclinical and clinical trials |
| Evidence of efficacy | Bioequivalence with the reference | Full clinical programme |
| Market entry | Only after the reference product's data and market protection expire | First on the market, sets the reference |
| Price | Lower, subject to price competition | Higher while protected, eroded after generic entry |
| Exclusivity of its own | None as a copy | 8 years data plus 2 years market protection, plus up to 1 year |
Against a biosimilar the difference is more fundamental. A generic is a chemically synthesised small molecule that can be reproduced identically, so it counts as the same substance as the originator. A biosimilar is a large biological molecule grown in living cells that cannot be copied exactly, only made highly similar, and it is approved through a different, comparability-based route. The two are not interchangeable concepts, and the biosimilar entry sets out that distinction in full.
Almost every German cost-containment instrument acts on the generic rather than the originator, because that is where interchangeable competition exists. Three mechanisms work together.
All three presuppose that an interchangeable generic exists. That is why the article data has to state, per pack, whether a product is a generic and which substitution and pricing groups it belongs to. For a pharmacy or a payer the practical consequence is that the generic status is not a label of convenience but the trigger for a whole set of legal and commercial rules, and reading it correctly per pack is what keeps dispensing and reimbursement compliant.
In the tabular article master data view the generic status is carried as a compact flag, and the substitution and pricing groups that act on it sit in the article comparison block, drawn from the licensed ABDA article master data.
One honest limitation: the GEN flag tells you a product is a generic and which groups it belongs to, but whether a specific substitution is permitted for a given patient still rests on the current §129 SGB V criteria, the G-BA Substitutionsausschlussliste and the fund-specific Rabattvertrag, all of which change over time. Treat the flag as a research aid, not as the dispensing decision.
