Are there any legal regulations in your country in relation to automatic substitution by biosimilar products? If yes, please provide the link to the website with the official document.
Uptake in Belgium is close to zero.
Information pertaining to the Belgian situation can be retrieved by following the link in attachment.
Kind regards
https://kce.fgov.be/publication/report/barriers-and-opportunities-for-the-uptake-of-biosimilar-medicines-in-belgium
In Mexico biosimilar products which demonstrate comparability, in terms of safety and efficacy trough physicochemical, preclinical and clinical studies, are able to substitute the reference product according to the regulation: NOM-177-SSA1-2013. However, many proposed biosimilar products are in the market without this type of studies, because the regulation started since 2013; this products have to demonstrate their efficacy and safety to renew their license.
The link of this document is:
http://www.dof.gob.mx/nota_detalle.php?codigo=5314833&fecha=20/09/2013
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