Robust development process - demonstrating biosimilarity
The main goal in biosimilar development is to confirm biosimilarity, which means to confirm that the proposed biosimilar is therapeutically equivalent to its reference medicine. Therefore, analytical, preclinical and clinical studies are performed to demonstrate that the biosimilar medicine matches the reference medicine, in terms of quality, safety and efficacy, demonstrating no clinically meaningful differences. This is based on the “totality of evidence concept”.2, 1
Biosimilars are approved via stringent regulatory pathways by the same regulatory authorities, such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) that approve reference medicines. They are manufactured with the same quality standards that are used for reference medicines.3,2
The stages of biosimilar development generate the totality of evidence, tailored to each molecule
This is different to development of reference medicines, where the focus is on proving clinical effect, however, both approaches provide the same level of confidence with regard to safety and efficacy of the biological medicine.
Extrapolation - A well-established scientific principle
Basic principle of extrapolation - The same molecule will behave the same way in all indications. Extrapolation is the scientific and regulatory process of granting a clinical indication to a medicine without conducting a clinical safety and efficacy study to support that indication.2-4 It has been applied to obtain approval after major changes in the manufacturing process or to introduce new formulations.
Sandoz is the pioneer and a global leader in biosimilars and has approved biosimilars in highly regulated markets of the US, Canada, EU, Japan and Australia.5-9
Variability of biologics
All biologics, whether reference medicine or biosimilar, are made by or extracted from living organisms. As a result of this and the complex manufacturing process, all biologics have a certain degree of inherent variability — no two batches are ever 100% identical.10
To manage this, any variation has to stay within precise ranges to maintain clinical safety and efficacy. These ranges are set and tightly controlled by both the regulatory authorities and the pharmaceutical company to ensure that all batches of any one biologic are delivering the same clinical outcome.11