Biologics

FDA Waives Efficacy Studies for Stelara Biosimilar

FDA has agreed to accept a biosimilar application that does not include clinical efficacy studies (CESs) for a monoclonal antibody, a step that could dramatically change how these drugs are developed and approved. The upcoming submission from University of Illinois adjunct professor and founder of several biopharmaceutical ventures Sarfaraz K. Niazi will seek approval for a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab), indicated for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. This marks the first time the agency has waived CES requirements for this class of biologics, according to Niazi.

CESs have long been a costly and time-consuming part of biosimilar development, though critics have argued they add little value in demonstrating equivalence when analytical and immunogenicity testing already confirm similarity to reference products. Niazi has spent years petitioning FDA and publishing peer-reviewed articles advocating for the elimination of CESs.

According to Niazi, removing the requirement could cut biosimilar development costs by more than 90% and shorten approval timelines by 70%, lowering barriers for smaller companies to enter the market. The move could also accelerate competition and reduce prices, potentially bringing cost savings similar to those seen with generic small-molecule drugs, he says, adding that it brings the agency closer in line with the European Medicines Agency and UK’s Medicines and Healthcare products Regulatory Agency, both of which have taken steps toward relaxing clinical trial requirements for biosimilars.

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