Drugs

FDA Approves Sandoz’ Prolia, Xgeva Biosimilars

FDA has approved Sandoz’ Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Prolia (denosumab) and Sandoz’ Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Xgeva (denosumab). An agency statement says Jubbonti is approved for the same treatment indications as Prolia, while Wyost is approved for the approved Xgeva indications.

The statement says approval of Jubbonti and Wyost was based on a comprehensive review of evidence demonstrating the products are highly similar to Prolia and Xgeva and that there are no clinically meaningful differences between the two product pairs.

The side effects and adverse events observed in trials of Jubbonti and Wyost were consistent with those observed with Prolia and Xgeva, FDA says.

An agency 1/19 Drug Safety Communication said FDA had added a Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking Prolia for osteoporosis. A similar Boxed Warning is part of the Jubbonti labeling, it says.

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