SP0027 Biosimilars: Potential Clinical Differences and European Regulatory Aspects

2014

Although successful drugs, the use of anti-TNFs is limited by their high cost, and in the present climate of economic difficulty, there is pressure to find alternatives that reproduce their effects at a lower price. Due to their large molecular size and structural complexity, anti-TNFs are impossible to duplicate, unlike smaller, chemically-generated compounds, which can be copied. However, unlike generics, biosimilars are similar rather than identical to the original drugs. Determining the level of similarity that guarantees a comparable efficacy and safety represents a new test for the pharmacological market. Biosimilars of smaller biological molecules, such as somatotropin, EPO and GCSF …