Drugs

Views on Biosimilar Competitive Marketplace

Commenting on a 3/9 FDA/Federal Trade Commission workshop on a competitive marketplace for biosimilars, Pfizer says it welcomes steps FDA has taken to address misinformation about the products. The steps include publishing a draft guidance providing that reference product promotional materials should avoid representing or suggesting that a biosimilar product is less safe or effective than its reference product because it has not been studied in all clinical indications or is not licensed as interchangeable. The Pfizer comment letter says it also appreciates that an FDA draft guidance acknowledges that firms can communicate data and information from studies conducted to support a demonstration of biosimilarity to healthcare providers or other interested parties, even if such studies are not included in the product’s approved labeling.

In its comments, the Biosimilars Forum says that negative education campaigns have included disparaging and at times factually incorrect or incomplete information. “Continued misleading and disparaging information about biosimilars will have a negative impact on the U.S. healthcare system, physicians and patients, ultimately leading to ongoing lost cost savings and low uptake of biosimilars,” it says. The letter raises concerns about perceptions, the biologics naming convention, substitution and interchangeability, and impact.

The forum suggests that FDA issue educational materials covering topics that have been the subject of misinformation and that the agency create a core curriculum to be used in medical, nursing, and pharmacy schools to complement educational programs targeting healthcare professionals.

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