Bio-Thera biosimilar to J&J’s Stelara under FDA review

Chinese pharmaceutical company Bio-Thera Solutions announced Wednesday that the U.S. FDA accepted its marketing application for BAT2206, its biosimilar targeted at Johnson & Johnson’s (NYSE:JNJ) blockbuster Crohn’s disease therapy Stelara.

With its Biologics License Applications, Guangzhou-based Bio-Thera seeks FDA nod to market BAT2206 with an interchangeable designation, which allows pharmacists to substitute the reference product without the advice of clinicians.

Concurrently, the company announced that the EU drug regulator, the European Medicines Agency (EMA), also accepted its marketing authorization application for BAT2206. Another application for the treatment is currently under review for marketing approval in China.

Bio-Thera highlighted the decisions as a significant milestone, noting that it was the first time a Stelara biosimilar developed by a Chinese company was the subject of a marketing application submitted to the FDA or EMA for approval.