More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

Japan’s Meiji Seika Pharma and Korea’s Dong-A have struck an exclusive licensing deal with Intas for global rights to the pair’s DMB-3115 proposed ustekinumab biosimilar to Stelara.

After immuno-oncology, mRNA is fast becoming a hot area in China as a flurry of biotechs from I-Mab to Kangtai partner with a little-known developer.

Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.