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January 2013, European Procurement & Public Private Partnership Law Review
November 30, 2016, Inside EU Life Sciences
On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017. Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars. In particular, Article 59(11) of the Draft Law provides that: two products enjoy a biosimilarity relationship only where this has … Continue ...
August 3, 2016, Inside EU Life Sciences
Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars. The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector. The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013. Overall, the Concept … ...
September 7, 2015, SCRIP Regulatory Affairs
Mr. Tosoni was quoted in this article.