Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of Intas, on 23 June, and the EMA accepted the MAA submission on 14 July. Intas will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.
On 22 July 2021, Intas Pharma announced it had signed a commercialisation agreement with Meiji and Dong-A St, under which Intas receives exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.