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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 access fo

United statesPeter steinMylan semgleeOffice of new drugsDrug administrationBiosimilars action planFederal trade commissionNew drugsDrug evaluationஒன்றுபட்டது மாநிலங்களில்பீட்டர் ஸ்டீன்அலுவலகம் ஆஃப் புதியது மருந்துகள்கூட்டாட்சியின் வர்த்தகம் தரகுபுதியது மருந்துகள்மருந்து மதிப்பீடு