Several publications show that the main added value of biosimilar medication is that it offers more patients the opportunity of access to biologic treatments. In other words, patients are the main beneficiaries of the inclusion of biosimilar medication in the health system, either by the cost savings in relation to the original product or by competitiveness.
The equivalence between the original product and the biosimilar one must be measured according to a thorough “comparability exercise”. The goal of this procedure is to demonstrate that the subtle differences inherent to the biologic origin and the productive process of both compounds do not have an impact on the risk-benefit ratio. This leads to the assertion that the active substances in both types of medication are, essentially, the same.
Biosimilar approval is supported by strict medical scientific evidence, and the regulatory authorities apply the same criteria for original biologics and biosimilars, according to the level of demand within the risk-benefit ratio deemed acceptable. Once the equivalence and the product have been authorized by the healthcare authority, the biosimilar is the same as any other biologic medicinal product.
The equivalence between the original product and the biosimilar one must be measured according to a thorough “comparability exercise”. The goal of this procedure is to demonstrate that the subtle differences inherent to the biologic origin and the productive process of both compounds do not have an impact on the risk-benefit ratio. This leads to the assertion that the active substances in both types of medication are, essentially, the same.
Biosimilar approval is supported by strict medical scientific evidence, and the regulatory authorities apply the same criteria for original biologics and biosimilars, according to the level of demand within the risk-benefit ratio deemed acceptable. Once the equivalence and the product have been authorized by the healthcare authority, the biosimilar is the same as any other biologic medicinal product.