Biologics

Fresenius/Formycon Stelara Biosimilar Approved

FDA has approved Fresenius Kabi and Formycon’s biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnson’s referenced Stelara, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The biosimilar was approved for both subcutaneous and intravenous formulations.

Ustekinumab is described as a monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play a role in inflammatory and immune responses. “The FDA approval of Otulfi (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data,” the companies say. “Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).”

Fresenius and Formycon say that under an earlier patent settlement with Johnson & Johnson the biosimilar will be launched 2/2025.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome