Biotechnological medicinal products and biosimilars: what clinicians should know when prescribing biosimilars
Summary. Summary. The article devoted to problems of use of biological/biotechnological products, which are claimed to be similar to reference products with the same biological molecule (active substance). There were considered peculiarities of biological/biotechnological products, including immunogenicity, pharmacovigilance and biosimilars safety monitoring. the overview of biosimilars regulation in EC is provided. the key aspects of program statement of International Federation of Pharmaceutical Manufacturers and Associations related to further presence of «non-comparable biotherapeutic products» at the pharmaceutical market are given.
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