Drugs

FDA Will Review sBLA for Humira Biosimilar

FDA has accepted for review a Samsung Bioepis/Organon sBLA for their citrate-free, high-concentration formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing AbbVie’s Humira (adalimumab). A Samsung statement says FDA previously approved SB5 as

Hadlima, a low-concentration formulation of Humira, in 7/2019.

Samsung Bioepis submitted the sBLA for citrate-free high-concentration adalimumab 10/2021 based on clinical data from a study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of the two formulations of SB5 in healthy volunteers.

The company says SB5 will be commercialized in the U.S. by Organon and is expected to launch on or after 7/1/23 under a licensing agreement with AbbVie.

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