Biologics

Alvotech/Teva’s Stelara Biosimilar Approved

FDA has approved Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnson’s Stelara, for treating moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older. “Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success,” the companies say. Selarsdi is expected to be marketed in the U.S. on or after 2/21/2025 under a settlement agreement with Johnson & Johnson.

Ustekinumab is a monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin IL-12 and IL-23 cytokines, “which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis,” Alvotech and Selarsdi say. Alvotech developed and produces Selarsdi using Sp2/0 cells and a continuous perfusion process, the same type of host cell line and process used in Stelara’s production, they say.

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