Drugs

Guide on Insulin Biosimilar Immunogenicity

FDA has issued a draft guidance on “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document is intended to clarify what data and information may or may not be needed to support a biosimilarity or interchangeability demonstration for a proposed insulin product. The draft also reflects input from stakeholders provided at a 5/19 agency public hearing.

Significantly, the guidance recommends that, “under certain circumstances, a comparative clinical immunogenicity study would not be necessary for approval of certain proposed biosimilar and interchangeable insulin products. In general, immunogenicity studies investigate the presence of an immune response to the therapeutic protein and its clinical impact, which can influence whether the therapy will work well and be safe.”

In these circumstances, FDA says, the risk of clinical impact from immunogenicity should be minimal for certain proposed biosimilar and interchangeable insulin products. “As such, while applications for biosimilar and interchangeable insulin products would be expected to include an immunogenicity assessment, that assessment could include a scientific justification of why a comparative clinical study to assess immunogenicity is not necessary for that particular proposed insulin product,” it says.

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

Read more

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