Samsung Bioepis has announced that its SB17 proposed biosimilar ustekinumab rival to Janssen’s $7.7bn Stelara brand has moved into Phase I trials.
The Samsung Bioepis joint venture between Biogen and Samsung Biologics has announced that its SB17 proposed biosimilar rival to Janssen’s Stelara (ustekinumab) has moved into Phase I trials.
The randomized, double-blind, three-arm, parallel, single-dose study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Stelara and SB17 in healthy male volunteers
Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
