A biological medicine that is similar to another biological medicine that has already been authorized for use. Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium or yeast. They can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies. (EMA) The point in favor of biosimilars is the cost advantage.
Clinical studies are required to be conducted on biosimilar to prove its similarity to reference product and absence of any meaningful difference from the reference medicine in terms of quality safety and efficacy.
CBCC- Vibgyor provides strong investigators network for biosimilar clinical trials across India and USA. Reach us to develop the biosimilar and realize the potential of quality, time and cost effective approaches.