Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the writing of pharmacovigilance documents, such as DSURs, RMPs, and PSURs, for submission to health agencies. Due to the nature of biosimilars and generics, the medical writerneeds to take into account some specifics while preparing pharmacovigilance documents.