Biologics

Sandoz BLA Filed for Tysabri Biosimilar

FDA has accepted for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogen’s Tysabri (natalizumab). The submission seeks approval for all indications of the reference product, which include relapsing forms of multiple sclerosis including clinically isolated syndrome, relapsing-remitting MS, active secondary progressive disease in adults, and Crohn’s Disease. A similar submission was also recently accepted by the European Medicines Agency.

Sandoz says the product was developed by Polpharma Biologics. Under a commercialization agreement, Polpharma will maintain responsibility for development, manufacturing and supply, and Sandoz has the rights to commercialize and distribute the product in all markets, it says.

The biosimilar was developed to have the same intravenous dosage form, route of administration, and dosing regimen as the reference medicine, Sandoz says. The BLA includes a comprehensive analytical, preclinical and clinical data package, it says, adding that the Phase 1 and Phase 3 Antelope studies in multiple sclerosis patients met their primary endpoints, “showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity.”

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