Biologics

Biosimilar Program Review Finds Higher First-Cycle Approvals

An independent review of FDA’s user fee program for biosimilars found that first-cycle approval rates were higher (67%, 14 of 21) during the first four years of the current five-year program than during the program’s 2013-2017 baseline first five years (39%, 9 of 23). The assessment said that “based on the quantitative data, observations, and feedback from interviews, it is reasonable to conclude that the BsUFA II Program has created conditions that enhance the ability of applicants and FDA reviewers to work toward application approval in the first review cycle.”

Data from the current biosimilar user fee program also suggest a possible relationship between an application’s proposed indications and first-cycle approval. The assessment found that “applications with hematologic or solely oncologic indications were less likely to receive a first-cycle approval (33%, 3 of 9) than applications with other indications (92%, 11 of 12).” It found that baseline and BsUFA II program applications with a major amendment were associated with a higher first-cycle approval rate (100%, 3 of 3 baseline, 1 of 1 BsUFA II program) than those without a major amendment (30%, 6 of 20 for baseline; 65%, 13 of 20 for BsUFA II program). “This aligns with the expectation that FDA will accept and review a major amendment when the agency believes that this will lead to approval in the first cycle rather than requiring resubmission and a second cycle of review,” it says.

Additionally, product quality and facilities approvability issues were commonly cited in baseline and BsUFA 2 complete response (CR) letters, it says. “Sponsors of baseline applications with first-cycle CR letters due to product quality and facilities issues often resubmitted their applications and gained FDA approval in subsequent review cycles. Nearly all of the (BsUFA II) Program applications that received a first-cycle approval were submitted by sponsors who had previous applications approved in the baseline (first or subsequent cycles). This might suggest that sponsors possessing biosimilar product quality and facilities expertise, whether gained through experience or through external hiring, consulting, and contracting, are more likely to receive first-cycle approval.”

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