Drugs

No Safety Issues in Biosimilar Switches: Study

FDA researchers who conducted a review and meta-analysis of safety outcomes when switching between biosimilars and reference biologics report no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or biosimilar. “The results demonstrate that the incidence and nature of safety events observed in patients who were switched to or from a biosimilar product and its corresponding reference biologic once or multiple times are not statistically different from those in patients who were not switched,” the researchers conclude.

The study was published in the open-access PLOS ONE journal.

The researchers say that under the law, the risk of switching between a reference product and an interchangeable product must not be greater than the risk of using the reference product without switching. They say a switching study may be performed to address that switching standard. Such studies often contain at least two alternating exposures of the proposed interchangeable product and the reference biologic, resulting in at least three switches, they write.

“The findings here support reducing the regulatory burden of switching studies as the default approach for addressing the switching standard for the interchangeable designation,” the report says. “This work also supports reassessing the need for switches included in clinical studies for candidate biosimilars as an approved biosimilar will be analytically highly similar to its reference product. As familiarity with and understanding of the rigor of the analytical comparisons used to support biosimilar approvals increases, the amount and type of clinical data routinely performed as part of biosimilar development may be reduced, which in turn would reduce the time and cost of development.”

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