Generics, Biologics and Biosimilars

Abstract Pharmaceutical products are not limited to therapeutic drugs and biologics. These pharmaceutical products are regulated by different branches of medicinal product’s regulatory agency. In the US, the center for drugs evaluation and research (CDER) reviews and regulates drugs (brand and generic) while the center for biologics evaluation and research (CBER) reviews and regulates biologics, biogenetics, biosimilar, etc. (vaccines, protein-based products, etc.) (NG, 2009). Under each regulatory umbrella, the regulatory oversight and status are different, but in all cases, the main objective is ensuring adequate safety and efficacy evaluation of investigational products intended for a clinical trial or marketing purposes. The evaluation of generic, or biologic or biosimilar product by a regulatory agency follow set standards either for a pre-clinical trial in animals or clinical trial in humans. Some of these standards are not limited to safety, efficacy, patent’s rights, biological and chemical characterization of the product. These criteria are

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