Biosimilarity Study Regarding Product Quality of Candidate Recombinant Monoclonal Antibodies as Biosimilars / 中国药学杂志

ABSTRACT

OBJECTIVE: Nowadays, recombinant monoclonal antibodies developed as biosimilar domains in application category for Investigational New Drug in domestic. The quality similarity should be prequalified for candidate drug to be developed as biosimilar. Here, the concept of quality biosimilarity was proposed and discussed from reviewer as well as developer. METHODS: The challenge of developing and evaluating biosimilar antibodies was emphasized. Then, the domestic sponsor's common problems were sorted out and critical quality attributes of some originator antibodies were summarized. Lastly, the reasons of holding letter or case rejected were exemplified and analyzed. RESULTS: AND CONCLUSION: The sponsor are encouraged to conduct comparing exercise by state-of-art analytical technologies to conform the quality similarity between a proposed biosimilar antibody and the originator product, the reviewers should also be very cautious to assess quality differences. Joint efforts and effective communication from researcher and reviewer are critical for promoting development of domestic biosimilar and addressing the unmet medicine need.