Biological medicinal products: reference and biosimilar products – selected issues
نویسندگان
چکیده
Biological therapies are being used in many chronic conditions. Development of biosimilar medicines gives chances for wider access to biological treatment. The aim the review was present legal regulations marketing authorisation context biosimilars medicines. article focuses on legislation European Union, which established beginning XXI century and is very complex strict. In first part were described basic terms this field, such as medicine, reference medicine generic medicie. It also shows differnces between Main difference concerns manufacturing process, because will never be identical medicine. Next concentrates proces registration new medicines, especially area medicines’ indications use controversies related them. last presents issues safety monitoring european level. purpose law that field guarantee every registred biologic therapy safe patients.
منابع مشابه
Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
متن کامل
Biosimilar medical products - licensing, pharmacovigilance and interchangeability.
The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimil...
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T he Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and regulatory aspects in the development of biosimilar products. Such products are becoming an increasingly important area of interest for both the biopharmaceutical industry and regulatory agencies. Biosimilars are highly complex, and scientists have be...
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ژورنال
عنوان ژورنال: Journal of Education, Health and Sport
سال: 2021
ISSN: ['2391-8306']
DOI: https://doi.org/10.12775/jehs.2021.11.10.005