09/05/2024
Through a selection process, Mikrobiomik has been selected to participate in the Market Access Mentoring Programme, promoted by AseBio (Spanish Association of Biocompanies). The programme grants valuable mentoring hours given by the renowned global consultancy Alira Health, who will provide us in exclusive advice to face the challenge of being the first company worldwide to market in the EU, the first biological medicine based on intestinal microbiota (MBK-01).
Mikrobiomik is progressing well in the development of the regulatory dossier that is planning to submit this year to the EMA (European Medicines Agency) through a centralized submission process.
The aim of Market Access is to ensure that MBK-01 will be available on the European market after appropriate pricing and reimbursement negotiations with healthcare systems. Patients affected by Clostridioides Difficile infection will be able to access the medicine from the second half of 2025.
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