On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same
Category Archives: Global Comparisons
Subscribe to Global Comparisons RSS FeedBiosimilar 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
Netherlands MEB revises position on biosimilars and interchangeability
The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions. The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous position of 2010. The 2010 position provided that patients should be kept at the same
EMA releases a draft revision to the Biosimilars Guideline for public consultation
The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.
EMA regulatory approval changes for biosimilars on the horizon in the E.U.?
As mentioned in a previous post, the EMA set the standard for regulatory approval of biosimilars* with the adoption of their overarching general guideline in 2005 (CHMP/437/04 — PDF), followed shortly thereafter by guidelines on quality issues (EMEA/CHMP/BWP/49348/2005 — PDF) and on non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 — PDF). The pathway for biosimilar approval was
Global Dis-Harmonization of Biosimilar Naming and Labeling
The Food and Drug Law Institute held a recent “Dialogue” on the naming and labeling of biosimilars in the U.S. as the Food and Drug Administration (FDA) implements the abbreviated pathway for biosimilars authorized under the Biologics Price Competition and Innovation Act. While the representatives from FDA participated on both panels—naming and labeling, the remainder