Generics and Biosimilars
|EUPATI Open Classroom
|Types of Medicines and Their Mode of Action and Use
|Generics and Biosimilars
|Saturday, 24 February 2024, 8:00 AM
1. Generic medicines
(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)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
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.
2. BiosimilarsThe European legislation defines a biosimilar as ‘a biological medicine that has been developed to be similar to an existing biological medicine’. A biosimilar mimics the effects of a previously approved biologic medicine and is intended to treat the same disease or diseases.
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 copy of the medicine with the same active ingredient. These copies have been given the name ‘similar biological medicinal products’ or ‘biosimilars’. Biosimilars and original biologic medicines will differ in appearance, brand name and packaging, although the dose and how the medicines are given (by injection under the skin, into a muscle or directly into a vein) remain the same.
2.1. General features
2.2. Use of biosimilarsBiosimilars are used to treat the same diseases as the original biologic medicine (see Biologics section for more details). A list of currently available biosimilars agents in Europe can be found on the EMA website.
2.3. Production processBiosimilars are developed in the same way as the original biologic medicine they copy. They are manufactured using living cells that have had a vector carrying genetic information (deoxyribonucleic acid; DNA) inserted into them. This vector contains specific information that allows cells to produce the proteins that form the active components of biosimilars (see the Biologics section for more details). The exact source of the living cells (i.e. microorganism, animal or human) and the specific production techniques used to manufacture biosimilars may, however, vary from those used to manufacture the original biologic medicine. Nevertheless, biosimilars are produced to the same high standards required of the original biologic medicines.
2.4. Approval process
- European Medicines Agency, 2012. Questions and answers on biosimilar medicines (similar biological medicinal products). Available from: https://www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf (Accessed 3 March 2014).
- European Medicines Agency, 2013. Biosimilar medicinal products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf (Accessed 3 March 2014).
- European Medicines Agency, 2014. European public assessment reports. Available from: https://www.ema.europa.eu/en/medicines/what-we-publish-when/european-public-assessment-reports-background-context (Accessed 3 March 2014).