2. Biosimilars

2.4. Approval process

Biosimilars are regulated in the European legislation since 2003. Importantly, the regulatory approval requirements and post-marketing surveillance for biosimilars are much more rigorous than for traditional generic chemical medicines.

Unlike for generic chemical medicines, manufacturers are required to conduct clinical studies to demonstrate that the benefits (i.e. ability to treat a disease) and any potential risks (for example, the tendency to cause an immune response – an important consideration for biologic medicines) are comparable between the two medicines. Although the exact information required for approval is decided on a case-by-case basis, the amount of clinical data needed for a biosimilar is generally less than for the original biologic medicine. This is because the safety and effectiveness of the original medicine will have been well established over several years.

Consequently, some clinical studies will not need to be repeated for the biosimilar. The main aim of the evaluation is to establish that there are no major differences between the biosimilar and the original biologic medicine.