A document, drawn up by a study group on the recommendation of the Commission, underlines that the rules on substitutability between the originator and the biosimilar remain the responsibility of the individual States. Assogenerici: "Reaffirming the goodness of the approach of Italian producers"
22 APR – The rules on substitutability and interchangeability between the originator biotech drug and the biosimilar remain the responsibility of the individual States. Biosimilars are medicines which, in order to obtain this status, must demonstrate quality, safety and efficacy equal to the originators, validated through a regulatory process that can be superimposed for rigor and completeness, and with identical controls on materials and production technologies. This is what emerges from the consensus document on biosimilar drugs drawn up, on the recommendation of the European Commission, by the Steering group on Transparency and Ethics. As far as the biosimilars chapter is concerned, the contribution of the European Generic Medicine Association (Ega) with its European Biosimilars Group, and of other experts from organizations such as the Standing Committee of European Doctors (Cpme), the European Social Insurance Platform (Esip), the European Federation of Pharmaceutical Industries and Associations, as well as by patient associations and the Member States of the Union. The text also reiterates the fundamental role of these medicines in expanding the number of patients who can access these treatments, hitherto limited by the economic compatibility of health services.
"In the field of biosimilars, Europe today confirms its supremacy both from a regulatory and cultural point of view", commented Michael Uda, general manager of Assogenerici. The conclusions of the document confirm "the goodness of the approach adopted since the beginning by the producers of Italian biosimilars - added Uva - An approach that has been based on the continuous scientific exchange with the medical community and in the work of providing information on the characteristics of these medicines and on the concrete possibilities of maintaining high standards of care even in a phase of limitation of available resources and constant growth of hospital pharmaceutical expenditure. Counteracting the work of disinformation, which, as in the case of genres
