ustekinumab Archives

Janssen re-files motion for preliminary injunction regarding Amgen’s Stelara® (ustekinumab) biosimilar

by Bioblast Editor | Mar 6, 2023 | Biosimilars updates

Janssen Biotech, Inc. has filed another motion for a preliminary injunction against Amgen regarding its ustekinemab biosimilar, after its original motion was denied by US District Court Judge Noreika on 2 March 2023. Janssen is seeking to enjoin Amgen, Inc. from...

Long term data demonstrates Janssen’s Stelara® (ustekinumab) safety and efficacy

by Bioblast Editor | Mar 4, 2023 | Biosimilars updates

Janssen announced its positive long-term safety and clinical data for Stelara® (ustekinumab) in Chron’s disease and ulcerative colitis (five and four years respectively) at the ECCO Congress. The findings indicate that key safety events were similar between a placebo...

Janssen Biotech, Inc’s motion for preliminary injunction regarding Amgen’s Stelara® (ustekinemab) biosimilar denied by District Court judge

by Bioblast Editor | Mar 2, 2023 | Biosimilars updates, Patent Litigation

On Thursday, US District Court Judge Noreika denied a motion filed by Janssen Biotech, Inc (a Johnson & Johnson subsdiary) for a preliminary injunction regarding Amgen’s ustekinemab biosimilar, because the motion did not comply with the court’s page limit...

JSR’s Similis Bio and Novel351K announce biosimilars partnership

by Bioblast Editor | Feb 14, 2023 | Biosimilars Deals 2023, Biosimilars updates

JSR Life Sciences’ Similis Bio announced plans to enter into a partnership with Novel351K to co-develop three undisclosed biosimilar programs. Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP...

EMA accepts MAA for Alvotech’s AVT04 Stelara® (ustekinumab) biosimilar

by Bioblast Editor | Feb 9, 2023 | Biosimilars updates

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™. The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023. In January 2023, the FDA accepted for review the BLA...