Generics and Biosimilars

1. Generic medicines

When chemical medicines are first developed and approved, they are sold by a pharmaceutical company under a brand name. Once the protection for a product expires, e.g. patent or regulatory protection, the company no longer has exclusive rights to sell the medicine, and other companies can then manufacture and sell a comparable medicine with the same active ingredient; this new version is often referred to as a ‘generic’.

While two medicines, the original and the generic, will have different brand names and packaging, they will have the same active ingredients and, effectively, can be considered to be the same medicine. This could cause some confusion if it were not for the generic name of the active ingredient, which is shared by all brands of the medicine. This is common for pain medications, for which active ingredients, such as paracetamol, acetylsalicylic acid and ibuprofen, are used as the basis for many of the painkillers that can be bought in pharmacies.

Notably, approved generic medicines are regulated in the same way as the original medicines, and manufacturing facilities and conditions must equally be of a very high standard. The generic medicine is tested to ensure that it has the same properties as the original, bioequivalence has to be shown. This means that the generic medicine is absorbed in the body to the same extent and at the same speed as the original. However, the sometimes lengthy and costly steps of clinical trials to show efficacy and safety do not have to be repeated. Following the approval of a generic medicine, the company producing it must commit to collecting and reporting additional safety data.

Chemical medicines are less complex than biologic medicines and are therefore relatively inexpensive to manufacture. The key advantage for a generic medicine over the original is cost, with generics generally being cheaper than originals, and they are therefore preferred by many doctors and hospitals.