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
1Department of Surgery, “Sf. Ioan” Emergency Clinical Hospital, Faculty of Dental Medicine, “Carol Davila” University of
Medicine and Pharmacy, Bucharest, Romania
2Departament of Drug Control, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
3Department of Biochemistry and Molecular Biology, University of Bucharest, Romania
4Departament of Toxicology, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
5Departament of Pharmaceutical Physics and Informatics, Faculty of Pharmacy, “Carol Davila” University of Medicine and
Pharmacy, Bucharest, Romania
6Department 5, Faculty of General Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
7Department of Drug Analysis, Faculty of Pharmacy, “Ovidius” University, Constanța, Romania
8Department of Plastic and Reconstructive Surgery, “Sf. Ioan” Emergency Clinical Hospital, Faculty of General Medicine,
“Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
9Departament of Diabetes, Nutrition and Metabolic Diseases, Faculty of General Medicine, “Carol Davila” University of
Medicine and Pharmacy, Bucharest, Romania
*corresponding author: bianca.galateanu@gmail.com
#Authors with equal contribution
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Abstract:
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.

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