Data from Janssen’s phase 3b COSMOS clinical trial reveals that guselkumab (Tremfya), an inhibitor of interleukin-23 (IL-23), provides improvements in all minimal disease activity (MDA) domains for adults with active psoriatic arthritis (PsA). The benefits persist through week 48, even in patients who have seen inadequate responses to one or two tumor necrosis factor inhibitors…
Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance
The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This…
FDA, FTC want to encourage competition in biologics market
The FDA and U.S. Federal Trade Commission (FTC) announced today that they signed a joint statement to encourage collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. The two agencies said the statement sets out to address false or misleading promotion about biosimilars within the…