Shots:

• Preclinical studies of the proposed omalizumab biosimilar KA showed similarities to Xolair in terms of analytical characteristics, in vitro biological activity, pharmacology, and toxicology in animals. Omalizumab is a mAb targeting IgE used to treat mod. to sev. asthma
• Structure & binding activity were similar to the reference Xolair, no significant differences in pharmacological, PK, and toxicity profiles were observed. The mouse model's findings also revealed that in vivo pharmacologic effects were similar
• Additionally, KA has similar activity to the omalizumab reference product in cell-free, in vitro, and relevant in vivo preclinical models, and the results demand a clinical analysis of biosimilarity

Ref: Centre for Biosimilars | Image: BMS