What exactly are Biosimilars and why are they so important?
According to the US Food and Drug Administration (FDA) definition, Biosimilars are biological products such as drugs, proteins, peptides, and monoclonal antibodies that are very similar in safety, purity, and efficacy to that of US FDA approved original innovative medicinal products. Biosimilars have the same active biological component as the original medicinal product. However, they are different in terms of inactive components and methods of production. In contrast to original medicinal products, Biosimilars are allowed to have only minor changes in their inactive components, which involves extensive analytical studies. This includes the study of structure and function of biological products, determination of toxicity, and pharmacological studies involving the assessment of pharmacokinetic and pharmacodynamic profiles.
ATCS Inc is pleased to offer research-grade biosimilars for your research needs. These biosimilar antibodies can be used as controls for preclinical lead identification as well as the development of novel assays and to explore new avenues in biological research.
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