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FDA Releases First Long-Acting Insulin Analog to Aid Diabetics


Wednesday, August 4, 2021
Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee (insulin glargine) on July 28, 2021. Mylan’s Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is both biosimilar to and interchangeable with Lantus (insulin glargine) meaning it can be substituted for Lantus at the pharmacy level without the need for a prescription from a healthcare professional. This approval is important because it furthers FDA’s commitment to supporting a competitive marketplace for insulin products. The availability of interchangeable biosimilar products can provide more treatment options to patients, lowering the treatment costs and enabling greater acc ....

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These Are The Top Priorities Challenges For New CDER Director Patrizia Cavazzoni MD


These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D.
By Lowell M. Zeta and Lynn Mehler, Hogan Lovells
Scientific breakthroughs have revolutionized the development of new and more personalized therapies to address unmet medical needs through enhanced technologies and data-informed capabilities. Advances in data infrastructure, clinical trial design, and other medical product technologies and the 21st Century Cures Act and other legislation aim to bring new innovations to patients who need them faster. These developments are requiring the FDA to rethink the ways it applies and interprets the law and to speed up its efforts to adopt innovative scientific approaches to inform regulatory decisions that make products more effective, safer, and available sooner. ....

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