Biologics

Samsung's Soliris Biosimilar Approved

FDA has approved a Samsung Bioepis BLA for Epysqli (eculizumab-aagh) as a biosimilar to Alexion’s Soliris (eculizumab), indicated for treating patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and atypical hemolytic uremic syndrome.

The approval was based on a “totality of evidence” including analytical, non-clinical and clinical data demonstrating its similarity to Soliris, with no clinically meaningful differences between EPYSQLI and Soliris in terms of safety, purity and potency, Samsung says. “The randomized Phase I, double-blind, three-arm, parallel group, single-dose study in healthy volunteers (NCT03722329) demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, tolerability, and immunogenicity profiles between EPYSQLI and Soliris,” it says “The randomized Phase 3, double-blind, multicenter, cross-over study in PNH patients (NCT04058158) demonstrated clinical equivalence in efficacy, safety, PK, and immunogenicity between EPYSQLI and Soliris.

The approval also requires a black box warning that eculizumab (complement inhibitors) products increase the risk of serious infections caused by Neisseria meningitidis. “Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors,” the company says. “These infections may become rapidly life-threatening or fatal if not recognized and treated early.”

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