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A Chinese biopharmaceutical company announced that its biosimilar for golimumab, used in the treatment of rheumatoid arthritis, has received approval from the U.S. Food and Drug Administration.
The medication, known as BAT2506, will be available in both subcutaneous injection (Immgolis) and intravenous infusion (Immgolis Intri) formats. It is indicated for adult patients with moderate to severe rheumatoid arthritis when used alongside methotrexate. Additionally, the subcutaneous form can be prescribed for adults suffering from moderate to severe ulcerative colitis.
Golimumab is a monoclonal antibody that inhibits the binding of Tumor Necrosis Factor alpha (TNF-α) to its receptors, thereby blocking the abnormal inflammation associated with autoimmune conditions. This biosimilar is comparable to products such as Simponi and Simponi Aria, developed by Johnson & Johnson’s Janssen unit, and Gobivaz from the European biotech firm Alvotech.
Earlier this year, the drug gained approval in the European Union for treating several chronic inflammatory autoimmune diseases, under the name Gotenfia. Its application remains under review in both China and Brazil.
The company has secured licenses for BAT2506 in 118 countries and regions through agreements with five foreign pharmaceutical firms. These locations include the United States, European Union countries, India, the United Kingdom, Canada, Switzerland, Russia, several Latin American nations, members of the Commonwealth of Independent States, and multiple Southeast Asian countries.
Following the news, shares of the company closed up 1.8% at CNY19.80 (approximately USD2.91) per share, after earlier surging by as much as 7% during trading. The overall Shanghai stock market increased by 0.9% today.
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