At a very basic level a biosimilar can be seen as a duplication of a specific biologic medicine. The biosimilar will only be introduced to the market once the relevant patents have lapsed and the biosimilar has passed stringent regulatory evaluation processes1,3.
The Basics
Biosimilars versus biologics
Introduction of biologics
Biologics have been available in the European Union (EU) for more than 30 years. Since their introduction, these medicines 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.1
With the introduction of biosimilars, access to such biopharmaceutical medicines improved, sometimes significantly. Patients across the world, including South Africa, deserve access to safe biopharmaceutical medicines in their fights against disabling and life-threatening diseases.1
Biologics have had a meaningful impact on patient care1,2
Kidney Diseases
Diabetes
Hematologic Diseases
Respiratory Diseases
Cancers
Gastrointestinal Diseases
Inflammatory Diseases
Cardiovascular Diseases
Immunologic Diseases
Lysosomal Diseases
Rigorous regulatory processes
Given the rigorous regulatory processes to ensure the safety, quality, and efficacy of biosimilar medicines, patients can have peace of mind that the outcome of treatment with a biosimilar product will be the same as that of the original biologic.1,2,3
As mentioned previously, there are no clinically meaningful differences between the biosimilar product and the reference product in terms of safety, purity and potency.2 However, these clinical outcomes may now be attainable at a reduced cost. It should, however, be borne in mind that, due to the natural variability inherent to a production process that occurs in living cells or tissues and due to the more complex manufacturing processes required for biological medicines, it would be incorrect to regard a biosimilar simply as a generic of a biologic.
It is not possible to make such exact replicas due to the numerous differences that may exist at molecular level.3,4 As a result, biosimilars are extensively studied.3
Extensive studies
To ensure similarity between a biosimilar and its reference biologic, developers of biosimilars demonstrate during the development process that there are no clinically meaningful differences in the amino acid sequences of the medicine itself nor in the mechanisms of action of the two medicines.
While there may be differences when it comes to the manufacturing process, the host cell lines that produce the biopharmaceutical, the protein structure and the inactive ingredients, these differences are not significant enough to alter the biosimilar’s comparability to the reference product in terms of efficacy, quality, or safety.2,3
Features shared by a reference biologic and its biosimilar8,9,11
The amino acid sequence and the mechanism of action have no clinically meaningful differences.8,9
