ABSTRACT
In recent years, with the development of ophthalmic therapeutic drugs, the vitreous body, as a channel for the treatment of ophthalmic diseases, especially fundus diseases, has opened up a new therapeutic approach for various choroidal neovascular diseases, macular edema, uveitis and other diseases associated with fundus diseases, which is represented by wet age-related macular degeneration (wAMD). The drugs administered through the vitreous body mainly include ocular anti-vascular endothelial growth factor (VEGF) injections, microplasmin and hormones. For this kind of ophthalmic products, there are no clear technical guidelines and norms for non-clinical research at home and abroad. This article combines review practices and cases of marketed products to sort out the research progress and considerations on non-clinical studies of ophthalmic drugs dosing through the ocular vitreous body, in order to provide references for the research and evaluation of such drugs.
ABSTRACT
OBJECTIVE: To evaluate biosimilar products focus on the similarities in the quality, safety and eificacy between the candidate and reference products. METHODS: Comparative non-clinical studies should be conducted and stepwise development should be carried out to demonstrate the similarity in non-clinical study for the candidate and reference products. Usually the necessity and content of in vivo study are dependent on the results of previous comparative studies in vitro. RESULTS AND CONCLUSION: Determination of the non-clinical similarity should be based on the statistical analysis of the candidate and reference products. Evaluation for toxicity similarities can focus on toxicity profile in types and extent. The non-clinical similarities will affect the strategy of clinical trial for biosimilars.