Generic medicines (generics)
What are they?
Generic medicines, or generics, are medicines that contain the same active substance as an original product (the branded medicine). It works in the same way as the original product and gives the same side effects.
A generic medicine is actually a lawful copy of the original product:
- It contains the same active substance.
- It can be used for the same disease or condition, and
- It corresponds to the original medicine in terms of dose, safety, efficacy, strength and how to take it (as a tablet, lozenge, suppository or other).
A manufacturer bringing a new medicine onto the market is likely to hold a patent for the product for a given number of years. The patent prevents others from producing a corresponding product that treats the same condition or disease and contains the same active substance. Manufacturers take out patents because it is costly to develop new medicines. Once the patent expires, other companies can develop corresponding medicines with the same active substance for treatment of the same disease.
Authorisation and control of generic medicines – the rules in brief
Generic medicines and original medicines must satisfy the same requirements in relation to authorisation and quality control. Before a new medicine can be marketed in Denmark, it must be authorised by either the Danish Medicines Agency or by our colleagues in other drug regulatory authorities in Europe based on an application from the manufacturer. The manufacturer must describe in the application precisely how and where the medicine will be produced and what active substances will be used to produce it.
Each batch of manufactured medicines must undergo a quality control test – a test that has been harmonised throughout the EU. The quality control test is the company’s own way of verifying that the quality of the manufactured medicine is the same as the authorised medicine. It includes testing if the medicine contains exactly the amounts of ingredients as the approved medicine.
The authorisation procedures and quality controls apply to medicines manufactured inside and outside the EU.
Pharmaceutical manufacturers are supervised by either the Danish Medicines Agency or by our colleagues in other drug regulatory authorities in the EU.
Generic medicines must meet high standards to be authorised
A company applying for authorisation of a generic medicine must prove in the application that
- the active substance, i.e. what produces the medicine’s effect, is the same as that of the original product.
- the manufacturer is able to produce the medicine in accordance with applicable requirements.
- the right amount of active ingredient goes to the place in the body where it has an effect.
The excipients, or inactive ingredients, can differ from the original product, but the medicine must produce the same effect.
Evidence and trials
The manufacturer of the original product is required to carry out animal trials (toxicology studies) and human trials (clinical trials) to prove that the medicine is tolerated and produces the intended effect in relation to the disease or symptoms in question. The drug regulatory authorities then assess if it has been sufficiently established that the active substance contained in the current form (tablet, suppository, injection or other) produces a therapeutic effect on a given disease/symptom.
A company deciding to develop a generic version of the original product is not required to repeat these animal and human trials. This is because the active substances, the disease and way to take the medicine, etc. are the same as the original product.
However, as part of the application process, the manufacturer of the generic version will need to supply data from so-called “bioequivalence studies” to confirm that the medicine’s active ingredient is absorbed and excreted by the body at the same speed as the original product.
These bioequivalence studies are part of a quite comprehensive quality assurance process.
Quality assurance, control and supervision of authorised generic medicines
Once a medicine has been placed on the market, the Danish Medicines Agency continuously monitors the quality of the medicine, for instance through inspections and random checks, and monitors side effects.
The EU has adopted community requirements for the manufacture, testing and sale of medicines. The EU requirements also apply to medicines manufactured outside the EU. These community requirements help ensure that all the medicines that are available from pharmacies or retail outlets are of a high quality.
In order to check that manufactures and retailers meet the requirements, we regularly pay them inspection visits. At these inspections, we go through the production equipment, manufacturing processes, raw materials, analyses and documents.
We pay special attention to medicines manufactured in and imported from third countries. These medicines undergo a series of laboratory tests in a laboratory in the importing country before being released for sale. Each year, we also bring back around 300 medicines for testing in our own laboratory to verify that the medicines are of the right quality.
In addition to these control checks, EU regulations require manufacturers and retailers to obtain an authorisation from the drug regulatory authority in their country of establishment. By law, only companies holding this type of authorisation can receive and distribute medicines. This way we ensure that no distribution of medicines take place between companies that are not supervised by us.
Find out more about generic medicines and what it means for you:
Generic substitution – questions and answers