Biocon Biologics settles with Janssen Bmab 1200, a proposed Stelara biosimilar

Indian drugmaker Biocon (BSE: 532523) subsidiary Biocon Biologics has signed a settlement and license agreement with Janssen Biotech and its parent Johnson & Johnson (NYSE: JNJ) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab) in the USA.

The agreement licenses Biocon Biologics to launch in the USA, in February 2025, once approved by the US Food and Drug Administration (FDA). The FDA has accepted the company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Stelara is J&J’s best selling drug, with 2023 revenues hitting $10.86 billion, up 12% despite the advent of biosimilar competition in Europe. m

Biocon Biologics and Janssen have finalized the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US 10961307 before the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademarks Office.