Biosimilars Law Blog

25 May 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...

16 March 2016

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA)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...

31 August 2015

FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars

In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed...

08 July 2015

AbbVie Challenges FDA Biosimilar Labeling

In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio...

23 June 2015

FDA Updates U.S. Biosimilar Guidances

Five years after enactment of the BPCIA and following its first biosimilar approval, the U.S. Food and Drug Administration finalized its initial guidances describing the scientific and...

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