Drugs

GPhA Wants Biosimilar Review Process ‘Aligned’

The Generic Pharmaceutical Association (GPhA) says that one of the most important outcomes of a successful Biosimilar User Fee Act (BsUFA) reauthorization agreement would be “to align on a biosimilar review process that facilitates approval of biosimilar products developed in an efficient manner that capitalizes on the novel development pathway created under the Biologics Price Competition and Innovation Act.” The group’s comment letter says that BsUFA 2 should build on the framework laid in BsUFA 1 to enhance FDA-industry communications and transparency, allow for targeted clinical programs, rely on appropriate nonclinical data, and allow for demonstration of interchangeability. “Timely decisions on innovative regulatory approaches will enhance review efficiencies and help assure the most effective use of agency resources,” GPhA says.

The letter says the biosimilar review program would benefit from increased staffing to improve the prompt scheduling of pre-submission meetings, timeliness of review, and approval of the products. Other improvements it seeks include having advisory committees that review biosimilars increase the number of analytical and functional experts with a strong understanding of the science of comparison and the assessment of biosimilarity, and additional touch points before submission and during the review of a 351(k) BLA.

The Biotechnology Industry Organization says that BsUFA reauthorization should strive to (1) clarify and enhance the processes and tools FDA uses to regulate biosimilars, and (2) improve the transparency, sustainability, and financial accountability of the BsUFA program.

Pharmaceutical Research and Manufacturers of America says that the BsUFA agreement developed in 2012 “provides the agency with the resources and regulatory framework to meet its public health mission and ensure patient safety.” It says that BsUFA 2 and FDA’s continued policy development related to biosimilars should further advance these activities.

Finally, the Arthritis Foundation suggests that FDA consider these points when engaging with stakeholders on BsUFA 2: patient experiences, biosimilar naming and labeling, patient engagement, and agency resources.

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