biologics

Clostridioides difficile, commonly known as C. diff, is a significant health threat in the U.S. Recent estimates suggest that C. diff, a common bacteria, can cause infection in roughly 500,000 patients annually in the U.S., with around 30,000 of these cases resulting in death. “Actually, it’s more like 5 million when you think about it…

As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for…

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…

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…

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…