Drugs

No Safety Issues in Biosimilar Switches: CDER Research

CDER researchers who conducted a systematic review and meta-analysis to determine if there were safety outcome differences between individuals who switched between a biosimilar and a reference product and individuals who did not switch say there were no statistical differences in the number of deaths, non-fatal serious adverse events, and study discontinuations due to an adverse event. A Spotlight on CDER Science report says the study was conducted because patients and their healthcare providers still have reservations about switching a patient to a biosimilar when their condition is stable on the reference product.

The report says the investigators evaluated 21 biosimilars corresponding to eight different reference products, which translated to 5,252 participants who underwent at least one switch and 5,770 individuals who served as no-switch controls.

Based on the data from their evaluations, “the researchers concluded that there were no differences in the risk of death, serious adverse events, or treatment discontinuations between the switch and no-switch arms,” the report concludes. “These results were not affected by the reference product class, the direction of the switch (reference product to biosimilar or vice versa), or the number of switches (single switch vs. multiple switches). These findings are consistent with previously published non-statistical descriptive reviews of switching biosimilars. They provide additional evidence for patients and their healthcare providers that switching between biosimilars and their reference products is not associated with major safety events.”

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