Biologics

FDA Approves Lupin's Interchangeable Lucentis Biosimilar

FDA has approved a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.

Ranluspec references Lucentis, a vascular endothelial growth factor (VEGF) inhibitor widely used in ophthalmology to treat vision-threatening retinal diseases. The biosimilar is approved for the same major indications as the reference product, including neovascular, or wet, age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

According to the company, Ranluspec is the only interchangeable ranibizumab biosimilar approved in the U.S. in both vial and pre-filled syringe presentations. The FDA approved both dosage strengths marketed for Lucentis: 0.3 mg and 0.5 mg.

Ranibizumab works by binding to and inhibiting VEGF-A, a protein involved in the abnormal blood vessel growth and leakage that can lead to vision loss in retinal diseases, according to Lupin.

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