What are the scientific justification factors for biosimilars?
Date:2023-01-07
1. Comparability: It is essential to demonstrate that the biosimilar product is highly similar to the reference product in terms of its biochemical activity, safety and efficacy. Clinical trials are used to make sure that the safety and efficacy of the biosimilar are similar when compared with the reference product.
2. Clinical efficacy and safety trials: Trials are required to demonstrate that the biosimilar is both safe and effective in treating the same medical conditions as the reference product. The trials must show that there are no clinically meaningful differences between the two products.
3. Protein sequence similarities: Protein sequence similarities (i.e. amino acid sequence levels) between the reference product and the biosimilar should be 95%-100%, or else there could be potential risks of reduced efficacy, safety or immunogenicity.
4. Structural/functional characteristics: Biosimilars should have comparable physical characteristics, such as size, shape, and folding, as compared to the reference product.
5. Physicochemical characteristics: It is important to use quality control (QC) assays to make sure that the biosimilars have the same biological performance as the reference product.
6. Immunogenicity risk assessment: For a biosimilar to be approved, it needs to have an acceptable risk of generating an immune response in the patient due to the similarity in active ingredients. This is typically measured through the use of laboratory assays.
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