Drugs

FDA Issues Promotional Guide for Biosimilars/Reference Biologics

FDA has released a final guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” which is aimed at clarifying how pharmaceutical companies should promote prescription biologics, including biosimilars and interchangeable biosimilars, in advertising and labeling. The guidance, presented in a question-and-answer format, outlines the agency’s current thinking on ensuring that promotional communications are truthful, accurate, and non-misleading.

The guidance addresses firms’ questions about promoting reference biologics — original products licensed under section 351(a) of the Public Health Service Act — and biosimilar products licensed under section 351(k), including interchangeable biosimilars that can be substituted for the reference product without a healthcare provider’s intervention.

Key points from the guidance include:

Truthful and balanced communications: Companies must ensure promotional materials accurately reflect the safety and effectiveness of both reference products and biosimilars. Claims must be balanced, clearly present risks, and avoid creating misleading impressions of superiority or inferiority.
Correct product identification: Firms are advised to identify reference products, biosimilars, and interchangeable biosimilars clearly in all promotional communications. Proper naming—including proprietary, proper, and core names—is critical to avoid confusion.
Use of clinical data: Promotional materials can reference studies from the original reference product if such data are included in the FDA-approved labeling for the biosimilar. Firms must ensure that only relevant data for the licensed indications of the biosimilar are presented.
Avoiding misleading comparisons: FDA cautions against implying that minor differences in study outcomes or licensure pathways indicate clinically meaningful differences between reference products and biosimilars. Presentations suggesting that biosimilars are less safe or effective than reference products—or vice versa—could be considered misleading.
Interchangeability considerations: Promotional materials should not suggest that a biosimilar’s safety or efficacy is inferior because it is not licensed as interchangeable with a reference product. Likewise, communications should not imply that patients should avoid switching from a reference product to a biosimilar.

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