Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 28

Any drug may produce adverse reactions, with varying levels of severity and frequency. Not all adverse reactions are, however, identified before the approval of a new drug, some only being observed during post‐marketing use when the drug is prescribed more widely to patients, as opposed to only clinical trial participants.

As part of the marketing authorization for biologics, the sponsor must submit a pharmacovigilance plan as part of a risk management plan (RMP) to the relevant authorities in accordance with EU regulations.⁴⁹ Applicants seeking biosimilar approval also need to submit an RMP, as required for innovator biologics. The purpose of an RMP is to document the risk management system necessary to identify, characterize, and minimize a drug's significant risks. The plan should incorporate identified and potential risks outlining a plan for pharmacovigilance activities, to characterize and quantify clinically relevant risks, and to identify new adverse reactions and outline risk minimization measures.⁵⁰