Drugs

FTC Supports FDA Draft on Interchangeable Biosimilars

The Federal Trade Commission (FTC) has submitted a comment to FDA expressing its support for a draft guidance removing a prior recommendation that a biosimilar drug applicant had to submit clinical switching studies to demonstrate the biosimilar’s interchangeability with its reference drug. Under the FDA draft, applicants can submit a statement explaining why the existing data in a BLA would support the designation of the drug as interchangeable.

FTC says the change would provide flexibility that may expedite the approval process and reduce the burden and cost of showing that switching a patient from a biologic to a biosimilar is safe and effective. It says the draft also would help combat marketplace confusion about biosimilar safety and efficacy.

The comment says the draft guidance will help fully realize the goals of the 2009 Biologics Price Competition and Innovation Act to increase competition and innovation among biologics, which could lead to lower prices and increased choice for patients who depend on the life-saving medicines.

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