OVERVIEW OF BIOLOGIC PRODUCTS WITH MARKETING AUTHORIZATION APPROVAL FOR CLINICAL APPLICATION

Golchin, A and Roshangar, L and Ai, J and Kangari, P and Mohammad pour, SH (2021) OVERVIEW OF BIOLOGIC PRODUCTS WITH MARKETING AUTHORIZATION APPROVAL FOR CLINICAL APPLICATION. Studies in Medical Sciences, 31 (11). pp. 847-862.

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Abstract

Among the different fields of modern medical sciences, regenerative medicine has attracted the attention of many researchers and physicians. The development of this branch of medicine has increased hopes for the treatment of incurable diseases. As a new idea in regenerative medicine in interaction with tissue engineering and genetics, cell therapy has been able to snatch the lead in modern medical sciences and confirm the clinical use of several cell-based pharmaceutical products. Cell therapy aims to transplant healthy human cells to replace or repair damaged cells for therapeutic purposes. Hence, this study aims to introduce and review approved cell-based drugs that are currently used in therapy. Materials & Methods: This study is a non-systematic review in which all biological products with therapeutic approval worldwide were extracted and reported from relevant organizations' sites. Articles were also searched manually and electronically in PubMed, Scopus, and Science Direct databases. Results: Since cell therapy products are related to products based on gene therapy and tissue engineering, all biological products with clinical use approval were collected and introduced from different countries. In total, the United States with 16 products, South Korea with 14 products, and the European Union with 8 products had the highest number of cell therapy products, respectively. Conclusion: Due to the novelty of this branch of medicine and the entry of cell therapy-based products into the consumer market, a rising trend in production and attention to the future of reconstructive medicine and cell therapy is predictable

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