Drugs

Samsung Seeks Interchangeable Humira Biosimilar

FDA has accepted for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Abbvie’s Humira. The submission was based on data from a Phase 4 clinical study (NCT05510063) that assessed the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between high-concentration formulations of Humira and Hadlima versus patients receiving Humira continuously, according to the company.

“An interchangeability designation may play a role beyond enabling pharmacy substitution,” Samsung Bioepis says. “We believe that interchangeability could help increase physician confidence with prescribing biosimilars, especially in the high-concentration formulation which is used by the majority of Humira patients.”

Hadlima was first approved by FDA 7/2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. A high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector was approved 8/2022. The biosimilar is marketed by Organon, Samsung 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