Author: Miriam Capoulas (Pharmacist) Branded medicine indicates an original medicine that has a commercial name chosen by the pharmaceutical company that developed and markets it. Generic medicines are those that have the same active substance, dosage, pharmaceutical form and indications as the original medicine that serves as a reference. Generic medicines may exist for both over-the-counter and prescription medicines. On the outer packaging, generic medicines are identified in Portugal with the letters GM. Any medicine, whether original or generic, has a generic name , which corresponds to its active ingredient. The active ingredient corresponds to an international common name , which in Portugal is the basis of prescription. Generic medicines are often marketed under the generic name or with an approximate designation of that name when it is more complex. Medicines development and pricing Throughout the development of an original medicine and until it is commercialized (a process that can take years), its quality, safety and efficacy are studied in detail. This covers not only the active ingredient itself, but also its use in the chosen pharmaceutical form (tablet, syrup, suppository, among others), in a certain concentration and in the dosage (dose and interval between administrations) proposed for a given indication. All this development involves substantial costs. So, once commercialized, an original medicine is protected by a patent , which means that only the pharmaceutical company holding the patent will be able to commercialize it. Only after the expiration date of a patent, the generic medicines, that is, copies of the original medicine that was protected by the patent, can be produced and sold. The greater the scope of use of an original medicine, the faster and in greater numbers the respective generics appear on the market, after the respective patent expires. The active substance paracetamol with the brand name Ben-u-ron®, ibuprofen with the brand name Brufen®, and acetylsalicylic acid with the brand name Aspirin® are examples of brand name medicines that are well known for their extensive use and the existence of numerous generic medicines Manufacturers of generic medicines have the advantage of being exempt from carrying out several of the development steps required in the manufacture of original medicines , in addition to having information on the use of the original medicine in practical conditions, throughout the years of the patent's validity. Therefore, for pharmaceutical companies that manufacture and sell generic medicines the costs are lower than those incurred by pharmaceutical companies that developed the original medicine . So, it is understandable that generic medicines are cheaper than original brand medicines. The obligations of generic medicines In addition to the active ingredient (one or more), medicines have other components (excipients) that may have different functions, but do not have pharmacological activity. A generic medicine does not need to have exactly the same excipient composition and appearance as its original reference brand medicine. However, generic medicines must have in relation to the reference medicine: The same active substance, in the same concentration; The same pharmaceutical form; The same indications; The same safety and efficacy. In addition, it is also necessary for generic medicines: Demonstrate bioequivalence (having the same pharmacokinetic and pharmacodynamic properties) of the reference medicine. Being bioequivalent means that after administering the same dose of the generic medicine and the reference medicine, the same amount of active substance exists in the body for a certain period. If bioequivalence to the reference medicine cannot be demonstrated, pre-clinical and clinical trials must be carried out before a generic medicine can be authorized. Comply with the same regulatory requirements as reference medicines; Be subject to monitoring of their use after being marketed (pharmacovigilance). Currently, in Portugal, medicines are prescribed by active ingredient (INN) and never by the brand name of the medication. However, in the prescription, doctors can indicate whether or not a patient can opt for a generic medicine (if any) instead of the original medicine that is their reference. The content published in the Health Guide is intended for the general public and is provided for informational and educational purposes only. It does not replace individual medical assessment, diagnosis, or personalized clinical advice from a qualified healthcare professional. The content is produced or reviewed by physicians and other healthcare professionals at Hospital da Luz and is based on the knowledge available at the time of publication or the most recent update, as indicated at the beginning of each item.
