Biosimilar Drugs
DOI:
https://doi.org/10.55175/cdk.v50i9.725Keywords:
Biological medicine, biosimilar, drugsAbstract
Biological medicines are medicines that are made or derived from a biological source and as such are complex molecules, with inherent variability in their structure. A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety, and efficacy based on a comprehensive comparability exercise. Biologic products are widely used in treatment for neutropenia, cancer, inflammatory and autoimmune diseases, and enzyme or hormone deficiencies.
Obat-obatan biologis adalah obat-obatan yang dibuat atau berasal dari sumber biologis dan merupakan molekul kompleks, dengan variabilitas yang melekat pada strukturnya. Obat biosimilar adalah obat biologi yang sangat mirip dengan obat biologis lain yang sudah berlisensi untuk digunakan. Hal ini menunjukkan bahwa obat biologis terbukti tidak memiliki perbedaan bermakna secara klinis dari obat biologis pencetusnya dalam hal kualitas, keamanan, dan efikasi berdasarkan uji perbandingan secara komprehensif. Produk biologis banyak digunakan dalam pengobatan untuk neutropenia, kanker, penyakit inflamasi dan autoimun, dan enzim atau kekurangan hormon.
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