(Yicai) May 19 -- Bio-Thera Solutions said that the Chinese biopharmaceutical company's golimumab biosimilar for the treatment of rheumatoid arthritis has received approval from the US Food and Drug Administration.

BAT2506 will be available in the subcutaneous injection (Immgolis) and intravenous infusion (Immgolis Intri) formulations, which can be used to treat adult patients with moderately to severely active RA in combination with methotrexate, Guangzhou-based Bio-Thera announced late yesterday. The former can also be used for treating adult patients with moderately to severely active ulcerative colitis.

Golimumab is an antibody drug that prevents the binding of free and cell surface Tumor Necrosis Factor alpha to its receptors, thereby blocking the abnormal inflammatory response triggered by TNF-α, Bio-Thera noted. BAT2506 is a biosimilar to Simponi and Simponi Aria, developed by Johnson & Johnson's unit Janssen Pharmaceuticals, as well as Gobivaz, developed by the European biopharmaceutical firm Alvotech.

In February, BAT2506 received regulatory approval from the European Union for the treatment of several chronic inflammatory autoimmune diseases, under the brand name Gotenfia. The drug's application is under review in China and Brazil.

Through licensing agreements with five overseas pharmaceutical companies, BAT2506 has been given the nod in 118 countries and regions, including the United States, the EU, India, the United Kingdom, Canada, Switzerland, Russia, various countries in Latin America, the Commonwealth of Independent States members, and several Southeast Asian countries.

Shares of Bio-Thera [SHA: 688177] closed 1.8 percent higher at CNY19.80 (USD2.91) each today, after jumping by as much as 7 percent at one point. The broader Shanghai stock market rose 0.9 percent. 

Editor: Martin Kadiev