Abstract: Objective To evaluate the similarity in critical quality attributes and stability profiles between the insulin aspart biosimilar candidate and the reference product in order to offer technical guidance for enterprises and provide data for review and approval by regulators. Methods Based on the risk classification principles for critical quality attributes, multidimensional analytical methods were applied to evaluate the candidate biosimilar and the reference product in terms of structural characterization, purity and impurities, biological activity and stability. Results The candidate biosimilar was highly similar to the reference product in critical quality attributes and stability profiles. Conclusion The study of quality similarities underlies the evaluation of overall similarities of biosimilars and the extrapolation of indications. Similarity evaluation can yield scientific evidence to support subsequent non-clinical and clinical studies and facilitate the development and approval of domestic biosimilars of the same variety.

Key words: Insulin Aspart, Biosimilar, Critical Quality Attributes, Similarity Evaluation, Stability, Mice