biosimilar faqs

Frequently asked questions

This section contains some short answers to some of the most common questions patients may have on biosimilars. If you are looking for more in-depth answers, please visit the relevant sections on the website under the top menu.

What is a biological medicine?

A biological medicine is a medicine that has been produced by living organisms or that has been derived from living organisms. Such medicines consist mostly of proteins made up of amino acids, the building blocks of proteins, but sugars or other carbohydrates may be added to it. The production of a biologic medicine (or biologic for short) is possible through the use of biotechnology such as recombinant DNA technology.

With this technology it is possible to identify the gene responsible for the production of a specific sought-after protein known to perform a certain function in the human body. This gene is then introduced into other carrier cells (like bacteria or yeasts) that proliferate and so produce large amounts of the desired compound. Such a biological medicine is extensively tested and reviewed before it will be approved for use in humans.

What is a biosimilar medicine?

A biosimilar medicine (or biosimilar for short) is a medicine that has been developed as a highly similar copy of an original biologic. Because of the complexities surrounding proteins and their production in living tissues, it is not possible to produce exact copies of the original biologic, but there are no clinically meaningful differences between the biosimilar product and the reference product in terms of safety, purity, and potency. A biosimilar can be introduced to the market once the original biologic comes off patent.

Who reviews and approves biosimilar medicines for use in patients?

Before biosimilars can be used to treat patients in South Africa, they have to be registered with or approved by the SA Health Products Regulatory Authority (SAHPRA). SAHPRA is also responsible for the approval or registration of the originator/reference product. Hence the same rigour and approval standards apply to both biologics and biosimilars.

If I am using a biologic, can I switch to the biosimilar once it becomes available?

Yes, when, in a given clinical setting, one medicine is substituted with another that is equivalent, it is referred to as interchangeability. This can be done on the initiative or with the agreement of the prescribing doctor. Since biosimilars match their reference product in terms of quality, safety, and efficacy, a specific biosimilar can be used interchangeability with its reference product. A biologic and a biosimilar containing the same active ingredient (specific protein) will give the same treatment outcome.

Why do people say that a biosimilar is not tested in the same way as a biologic before approval for use in humans?

A biologic will be a new active substance when it is first introduced to the market with no previous knowledge of safety and efficacy, while a biosimilar builds on the knowledge of safety and efficacy from years of clinical use of the reference medicine. The fundamental principle underlying the development of any biosimilar is therefore comparability with the reference (or original) product. Since the safety and effectiveness of the reference biologic have already been established, it is not necessary to repeat all clinical studies on condition that the biosimilar medicine is very similar in structure and has the same biological activity. Therefore, clinical studies for biosimilars are designed to show that there are no clinically meaningful differences between the biosimilar and the reference medicine (i.e., to demonstrate biosimilarity).

Why use a biosimilar instead of a biologic?

Biosimilars are less expensive than biologics, although they provide the same clinical outcomes. Biologics have been available in the European Union (EU) for more than 30 years and they have revolutionised the management of some of the previously most difficult to treat diseases. Their efficacy is such that they have helped to prolong and improve the lives of numerous patients. Unfortunately, these medicines are very costly and not all patients who need them are able to afford them. With the introduction of biosimilars, access to such biopharmaceutical medicines improved, and more patients are now able to afford treatment. With such reductions in costs, it is also possible for medical aid schemes to provide benefits for these types of medicines.