mAbxience is a biotechnology company specialized in the research, development and manufacture of biosimilar monoclonal antibodies. It is part to the pharmaceutical Insud Pharma Group.
More info at mAbxience
3D scientific animation to explain the biosimilar medicines by drug examples and the molecular technology and concept of similarity in the monoclonal antibodies developing context.
Biosimilar medicines (or similar biological medicine) are biological medicines that contains a version of the active substance of an original biological product (reference product) for which equivalence has been demonstrated.
The similarity exercise ensures these attributes using state-of-the-art and highly sensitive analytical methods that determine the physicochemical structure and functional properties of the biosimilar as compared to the reference medicinal product.
Equivalence with the reference product must be established by means of an exhaustive “comparability exercise”. The object of this exercise is to demonstrate that the slight physicochemical differences that exist between the two products have no significant impact on the quality, efficacy and safety of the biosimilar, implying that the active substance of both medicinal products is essentially the same.