Abstract:
OBJECTIVE To standardize China's naming of biosimilar antibodies and improve the whole life cycle management system of biosimilar antibodies.
METHODS Carried on deep research into the naming principles of World Health Organization(WHO), EU, USA, Japan and China. And analyzed the effects of different naming methods towards drug life cycle management.
RESULTS At present, the naming principles of biosimilar antibodies were not the same at home and abroad, but they were based on the international nonproprietary names for pharmaceutical substances(INN) system established by WHO generally. Different naming methods would influence prescription safety, pharmacovigilance, the access and reimbursement of medical insurance.
CONCLUSION To be in line with the international standards step by step, it is suggested that the drug regulatory departments shall issue related documents about the naming of biosimilars according to the actual situation of our country as soon as possible, based on the INN system. Thus, the naming principles of biosimilar antibodies will be clear. In addition, to establish the whole life cycle management system of biosimilars, especially the antibodies, it is suggested to strengthen the administration of pharmacovigilance and make scientific and prudent decisions on the reimbursement of medical insurance about biosimilars.