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    Home > Medical News > Latest Medical News > Borui Biologics ``Infliximab'' biosimilar drug approved for marketing

    Borui Biologics ``Infliximab'' biosimilar drug approved for marketing

    • Last Update: 2021-11-05
    • Source: Internet
    • Author: User
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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.


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