Live Chat Support Software
800.227.0627

What is a biosimilar?

What is a biosimilar?


A biosimilar is a biopharmaceutical drug designed to have active properties similar to one that has previously been patentated and licensed also consider as "copycat drugs”. 

Biosimilars are biopharmaceutical drugs designed to have active properties similar to one that has previously been licensed and are also consider as "copycat drugs”. Biosimilars or follow-on biologics are biological medical products where the active drug substance is made by a living organism or derived from a living organism with the help of recombinant DNA or controlled gene expression methods.

Biosimilars of therapeutic proteins such as monoclonal antibodies or antibody drug conjugates are manufactured protein drugs regulated by the FDA. Commonly used analytical methods for the characterization of proteins includes methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, purity and impurity analyses. Key elements in the analysis of biosimilars entail strategies and practices that allow for method validation and method transfer. Regulatory compliance is needed at different stages of product development, the application of design of experiments (DOE) and QbD.