Bioequivalence vs. biosimilarity
Studies on bioequivalence of a drug are carried out by applying a set of biological and physicochemical analyses which are specifically selected to the distinct attributes of the protein in question. Those analyses are conducted in line with scientific guidelines, literature and discussions held with the regulator in the course of advisory processes. On the other hand, studies on biosimilarity of the drug allow in-depth understanding of the reference product's nature.
One of the greater challenges associated with ensuring a high-quality end product is the lack of knowledge about manufacturing processes to which the reference product was subjected. For that reason the analytical tools used to assess the quality of the created drug as well as its more advanced characteristics must be precise and accurate enough to gradually support and help understand its critical qualitative features.
In order to ensure the most up-to-date scientific and technical solutions used in the course of production processes, it might prove necessary to introduce certain modifications. Depending on the element which is subject to modification, it might be required to conduct a bioequivalence study in order to assess the product's quality. This study can be carried out both before and after the product is modified.
It is important to note that a bioequivalence study conducted at this stage can be less advanced than the final study the aim of which is to assess the biosimilarity of the obtained biosimilar as compared to the reference drug. Its objective is to demonstrate that the obtained end product is characterised by the same high quality as the original product and that the processes to which it was subjected during production had no negative impact on it. The advancement level of analytical tests to which the product is subjected depends on the depth and nature of the modifications which took place. Sometimes in vivo tests are sufficient, however, in the event of significant modifications associated with potential risk of impact on the product quality, non-clinical or clinical confirmation of the modifications' impact on the product may be required.