Biologics

FDA Panel Backs Remicade Biosimilar Product

FDA’s Arthritis Advisory Committee has voted 21 to 3 to support the approval of Celltrion’s proposed biosimilar CT-P13 after finding it highly similar to Janssen’s Remicade (infliximab). Panel members agreed with agency reviewers’ assessment that CT-P13 was highly similar, notwithstanding minor differences in clinically inactive components. “Review of an extensive battery of test results provided by Celltrion confirmed the relevance of comparative clinical and non-clinical data with EU-approved Remicade to support conclusions of biosimilarity to U.S.-licensed Remicade,” the reviewers noted in briefing documents released before the panel meeting.

Celltrion used a non-U.S.-licensed comparator (European Union-approved Remicade) in some studies intended to support a demonstration of biosimilarity to the U.S.-licensed reference product. “Accordingly, Celltrion was required to scientifically justify the relevance of that data by establishing an adequate scientific bridge between EU-approved Remicade, the U.S.-licensed reference product and CT-P13,” the agency said.

Panel members agreed that there is adequate evidence to extrapolate data from the clinical studies to support a determination of biosimilarity of CT-P13 for all indications for which Remicade is licensed — Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis, and adult and pediatric Crohn’s disease.

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