FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for...16 March 2016
Biosimilar switching: Dutch MoH announces the set-up of a national system for biological medicinal products
The Dutch Minister of Health (MoH) announced the set-up of a national system to trace the safety of biological medicinal products. The MoH expects an increase in the number of biosimilar prescriptions. The national system should contribute to a responsible use of such cheaper alternatives and as such lead to a sustainable Dutch healthcare system. With that this initiative also fits in the vision of the MoH on medicinal products as published earlier this year.
The MoH asked the Netherlands Pharmacovigilance Centre Lareb to set-up the national system and made fundings available for this (EUR 300.000,-). Lareb will start this Fall with monitoring 5 hospitals and will monitor patients that are prescribed with a biological medicinal product (biosimilar and/or innovator biological). Based on these experiences, Lareb will work on a proposal for a national system that ensures safe switching between biological medicinal products. The system also aims to strengthen the faith in biological medicinal products, which essentially appears to aim at strengthening trust in biosimilars.