Drugs

CDER Webinar on Improving Biosimilar Adoption

CDER has announced a 4/13 Webinar entitled “Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” The program is being presented by CDER’s Office of Clinical Pharmacology and the University of Maryland’s Center of Excellence in Regulatory Science and Innovation.

“Comparative analytical studies are the foundation to demonstrating biosimilarity,” an FDA notice says. “Comparative clinical studies (e.g., clinical pharmacology and comparative clinical studies) are conducted after extensive comparative analytical assessments have been completed. These clinical studies aim to demonstrate that there are no clinically meaningful differences between the biosimilar and reference products, in contrast to demonstrating clinical benefits for the approval of an innovator biological product. Clinical pharmacology data, including pharmacokinetic and when feasible pharmacodynamic data, have the potential to streamline biosimilar development programs, as comparative clinical studies are generally more costly and lengthy.”

The Webinar is intended to share experiences from academic clinicians on biosimilar successes and challenges, and to offer recommendatitons on how to improve the efficiency of biosimilar evaluation and adoption, including the role of clinical pharmacology. “Enhanced knowledge and adoption of biosimilar products will help provide more affordable choices for patients,” the agency says.

To register, visit here.

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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