As more patents on biological drugs expire, the market for generic copies of these products, referred to as „biosimilars“ or „biogenerics“, has been growing for years. „How similar is your biosimilar to the originator drug product?” is the crucial question to be answered, in order to receive authorization for its use. The regular authorities require you to prove a close similarity between your proposed biosimilar and the reference product in terms of structure, biological activity and efficacy, safety, and immunogenicity profile, notwithstanding minor differences in clinically inactive components of the complete formulation.
Nanolytics will provide you with insights into the behavior of your developmental biosimilar or the consistent manufacturing and safety of your launched biological drug. Close similarity is confirmed by fingerprinting, in particular via congruent sedimentation coefficient distributions. Any problems, such as arising from aggregation, can easily be identified at an early development stage.
CASE STUDY: Two antibodies: An originator (upper panel) and a biosimilar (lower panel).
Five originator as well as six biosimilar samples were analysed using SV with absorbance detection. The SCD of of the biosimilar candidates are similar to the originator samples.