Biosimilar FDA Approvals On the Horizon As More States Enact Substitution Laws

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products – GP2015, Sandoz’s biosimilar to Amgen’s Enbrel (etanercept); and ABP 501, Amgen’s biosimilar to Abbvie’s Humira (adalimumab).

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The Ninth Circuit Deems the Compensation of Outside Medical Reviewers Relevant in LTD Litigation, in Demer V MetLife

So the other particularly fascinating item – to me, anyway – that popped up in my twitter feed while I was on vacation was this important decision by the Ninth Circuit, Demer v. IBM and MetLife, addressing whether (and, if so, how) the number of reviews done by, and compensation earned by, outside medical reviewers used by an insurer to evaluate long term disability claims is relevant to arbitrary and capricious review.

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