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Text|Pharmaceutical Mission Hills
On September 28, the National Food and Drug Administration (NMPA) announced that the infliximab for injection declared by Hisun Biologics, a wholly-owned subsidiary of Zhejiang Borui Biopharmaceutical Co.
Screenshot source: NMPA official website
Infliximab is an anti-tumor necrosis factor (TNF-a) monoclonal antibody, the original drug is Johnson & Johnson's similar
Borui Bio's infliximab for injection is a gram-like biosimilar.
According to a public press release issued by Borui Bio, its infliximab for injection was developed in strict accordance with the guidelines for biosimilar drugs, and pharmacy, non-clinical and clinical trials (pharmacokinetics, effectiveness, safety and immunogenicity) Equal comparison study) The results of the comparison study are all highly similar to the original drug
Reference materials:
[1] On September 28, 2021, the drug approval document pending information is released.
[3] Zhejiang Hisun Pharmaceutical Co.