EMA accepts MAA for Dong-A ST’s Stelara biosimilar, DMB-3115

EMA accepts MAA for Dong-A ST’s Stelara biosimilar, DMB-3115

Dong-A ST, the South Korean pharmaceutical company, has received confirmation from the European Medicine Agency (EMA) of the acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (ustekinumab). The MAA was submitted to the EMA by Accord, a subsidiary of Intas Pharmaceuticals, on June 23rd, and the agency accepted the submission […]

Biocon Biologics signs licensing deal for two biosimilars with Yoshindo

Biocon Biologics signs licensing deal for two biosimilars with Yoshindo

Biocon Ltd. said that its subsidiary Biocon Biologics has signed an out-licensing agreement with Japanese pharma company Yoshindo Inc. for commercializing a couple of its pipeline biosimilar assets — bDenosumab and bUstekinumab in Japan. Ustekinumab is a biosimilar of the reference drug Stelara, which is a monoclonal antibody for the treatment of psoriasis, ulcerative colitis, […]

Bio-Thera, Hikma Pharmaceuticals sign $150m licensing deal for BAT2206

Bio-Thera, Hikma Pharmaceuticals sign $150m licensing deal for BAT2206

Chinese biopharma company Bio-Thera Solutions has signed a commercialization and license deal worth up to $150 million with Hikma Pharmaceuticals to commercialize the former’s BAT2206. BAT2206 is a monoclonal antibody, which is being developed by the UK-based pharma company as a biosimilar referencing Jansen’s Stelara (ustekinumab), in the US. Stelara is presently approved for the […]

Janssen bags Stelara FDA approval for ulcerative colitis treatment

Janssen bags Stelara FDA approval for ulcerative colitis treatment

Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis. Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, […]