A patent infringement lawsuit looks set to delay the launch of the fourth biosimilar to be approved in the US. Late last week the FDA approved Amgen’s biosimilar of Abbvie’s adalimumab (Humira) called ‘Amjevit’. In a statement the regulatory authority said the approval was based on a review of evidence including “structural and functional characterization, animal ...
FDA approves adalimumab biosimilar amid ongoing patent litigation
27 Sep 2016