Home-grown medicines will be approved for the first time to market autoimmune diseases

Source: Medical Network

Pharmaceutical Network on November 18th The reporter learned from the State Drug Administration that the application for listing registration of adalimumab injection (brand name: Geleb) was recently approved. This is the first adalimumab biosimilar approved in China, and its indications are autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis, and psoriasis.

According to reports, adalimumab injection is the world's first fully human anti-tumor necrosis factor ɑ (TNF-ɑ) monoclonal antibody approved for marketing, which specifically binds to soluble human TNF-ɑ and blocks its interaction with The interaction of TNF receptors p55 and p75 on the cell surface effectively blocks the inflammatory effect of TNF-ɑ. In addition, adalimumab may also eliminate some pathogenic target cells by binding to transmembrane TNF-ɑ, which can induce effects such as apoptosis.

The adalimumab injection approved this time is the first domestic product to be developed and declared according to the biosimilar approach using the original adalimumab as a reference drug, and has obtained major special support for the creation of major national science and technology new drugs. Through comprehensive quality similarity studies, non-clinical similarity studies and clinical comparison studies, the applicant guarantees that this product is highly similar to the reference drug that has been approved for marketing in terms of quality, safety and effectiveness. The approval of this product will provide new options for patient treatment.