Romanian Society of Pharmaceutical Sciences
 

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LONG-TERM SAFETY OF BIOSIMILAR MEDICINAL PRODUCTS – KEY FOR ADMINISTRATION?

OCTAV GINGHINĂ 1#, GEORGE TRAIAN ALEXANDRU BURCEA-DRAGOMIROIU 2, BIANCA GĂLĂȚEANU 3*, ARIANA HUDIȚĂ 3, SILVIA DRAGOMIR 4, DOINA DRĂGĂNESCU 5, ANDRA BĂLĂNESCU 6#, COSMIN ADRIAN ROȘCA 7#, CARMEN GIUGLEA 8#, DANIELA ELENA POPA 2, ANCA PANTEA-STOIAN 9#, CAROLINA NEGREI 4

1.Department of Surgery, “Sf. Ioan” Emergency Clinical Hospital, Faculty of Dental Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2.Departament of Drug Control, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
3.Department of Biochemistry and Molecular Biology, University of Bucharest, Romania
4.Departament of Toxicology, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
5.Departament of Pharmaceutical Physics and Informatics, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
6.Department 5, Faculty of General Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
7.Department of Drug Analysis, Faculty of Pharmacy, “Ovidius” University, Constanța, Romania
8.Department of Plastic and Reconstructive Surgery, “Sf. Ioan” Emergency Clinical Hospital, Faculty of General Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
9.Departament of Diabetes, Nutrition and Metabolic Diseases, Faculty of General Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

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The emergence of therapeutically effective biological agents has been a major breakthrough for the management of a wide range of chronic diseases with problematic, delayed or even lack of response to standard therapies, from psoriasis to atopic dermatitis, chronic urticaria, inflammatory bowel disease and rheumatoid arthritis. Biosimilar drugs are biological products as well, marketed as alternatives to the original biological medicine, whose safety and efficacy profile are very similar but not identical to the innovative biological medicinal product, which has already been authorised and placed on the market for 10 years or longer. In this review, we discuss complex issues such as the development of the biosimilar products, regulation aspects, safety and efficacy of biosimilar products as well as their use in clinical practice. Some extended reports are also addressed. By changing the context and providing a new option for mitigating increasing healthcare cost and improving the quality of life for more and more patients, biosimilar drugs are at the forefront of contemporary medicine.