DEVELOPMENT AND MARKETING AUTHORISATION OF BIOSIMILARS IN EU
Journal of International Research in Medical and Pharmaceutical Sciences, Volume 16, Issue 3,
A biosimilar is an item with natural beginning that is exceptionally practically equivalent to and with the shortfall of clinically significant contrasts from a predominant supported organic item. Administrative rules will refresh as often as possible for biosimilar improvement and endorsement. Companies and their contracting partners interested in entering the biosimilar market should be aware of all biosimilar standards and hurdles so that they can answer swiftly to any questions. The biosimilar industry appears appealing due to the potential for cost savings and efficiency, but regulatory, technological, and legal hurdles remain. A marketing permission must be given by the governing agency before any pharmaceutical product can be placed on the market. The primary goal of obtaining marketing authorization is to verify that the product is safe and effective, as well as that it is a high-quality medicine. Biosimilars were approved for the first time in a regulated market in the globe, and they play a vital role in ensuring the safety, quality, and accessibility of human, veterinary, cosmetic, and biological products. The guideline discusses biosimilar product restrictions as well as various fees for product approval. The European Union's regulatory rules and MAA criteria are described in this article.
- European Medicines Agency (EMA)
- European Commission (EC)
- Reference Medicinal Product (RMP)
- Chemistry Manufacturing Control (CMC)
- Marketing Authorization Application (MAA)
- Committee for Medicinal Products for Human Use (CHMP)
How to Cite
Available:https://www.sciencedirect. com/science/article/pii/S135963491 3700016
European Medicines Agency - Biosimilar medicines-marketing authorization.
Volume 2B Notice to Applicants Medicinal products for human use.
Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues.
Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: quality issues (revision 1).
QRD product information annotated template- EMA.
Tailored scientific advice to support step-by-step development of new biosimilars.
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