A review of recent FDA-approved biologic-device combination products
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J Guo, J Weng, Q Zhu, F Zhou, Q Chen, X Gu…
Journal of …, 2024
Elsevier
With the remarkably strong growth of the biopharmaceutical market, an increasing demand for self-administration and rising competitions attract substantial interest to the biologic-device combination products. The ease-of-use of biologic-device combination products can minimize dosing error, improve patient compliance and add value to the life-cycle management of biological products. As listed in the purple book issued by the US Food and Drug Administration (FDA), a total of 98 brand biologic-device combination products have …
