Biologics

Biosimilar Program at FDA Maturing: Woodcock

FDA acting commissioner Janet Woodcock says the once-fledgling biosimilar industry is becoming more mature following the introduction of the agency’s Biosimilar Product Development (BPD) Program three years ago. As of 5/1, 94 programs are enrolled in the BPD Program, she told the Association for Accessible Medicines annual conference last week.

“We’ve approved 29 biosimilars, 20 of which are currently marketed,” Woodcock said. “And CDER has received meeting requests to discuss the development of biosimilars for 43 different reference products. This is a significant bump compared to 12 approved and 4 marketed biosimilars when the Biosimilars Action Plan was released in July 2018, and the future looks even brighter.”

Woodcock told attendees that interest in biosimilar development “continues to be vigorous. We are working to build an even more robust, competitive market, and strengthen the efficiency of biosimilar development. We are also working on new education initiatives to develop curriculum for use in medical, nursing, and pharmacy schools and to expand the availability of continuing education for health care providers.”

Additionally, the agency continues to issue, revise, and finalize guidances on biosimilar development and have also deployed application review templates specific for 351(k) biosimilar BLAs to assist with reviews and improve information accessibility when reviews become public. “We also continue work on important efforts such as education and outreach, collaboration and communication with international regulatory authorities, and the Federal Trade Commission,” Woodcock said. And, CDER has been conducting research on using pharmacodynamic biomarkers to reduce the need for comparative clinical efficacy studies to speed up product development.

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