The so called original medicines are pharmaceuticals which are based on new chemical entities (NCE’s), new biological entities (NBE or Biologics) or a new formulation of an already known substance, the latter are often called speciality pharma. In order to get maximal earnings from the often very large investment in the development of the medicine, the pharmaceutical company almost always apply for a patent, and in this way gets the exclusive right to sell the product for a number of years. When the patent expires, other companies may manufacture equivalent medicines, called generics or generic medicines. In this way competition is created which contributes to great savings for both the society and the consumer. In several countries, e.g. Sweden and Denmark, rules exist concerning substitution, meaning that the pharmacies must replace prescription medicines with the cheapest available alternative. This contributes to a reduction of the society’s cost for prescription medicines.
Generic medicines contain the same active pharmaceutical ingredient in the same amount as the corresponding original medicines. The excipients may vary, and therefore the medicines may differ in appearance. Generic products carry a different name than the corresponding original drugs, but provide the same medical effect.
A generic medicine has the same quality- and safety profile as the original medicine. Generic medicines are often tested in clinical studies in healthy volunteers to ensure that they are equivalent to the original medicines. During the entire development- and production process the generic medicine must comply with the same standards of efficacy, safety and quality as the original medicine. The requirements are monitored and enforced by the relevant regulatory authorities (the national medicines’ agencies and the European Medicines Agency (EMA) both before and after the medicine is approved for sale. The Medical Products Agency decides which medicines are substitutable.