Addressing the FDA’s 2016 Agenda: Biosimilars Must be a Top Priority

via Morning Consult
March 16, 2016
By Bert Liang

These are eventful times for U.S. healthcare. Two of the most of the most significant developments over the last year were U.S. Food and Drug Administration’s (FDA’s) approval of the first biosimilar in the U.S. and, more recently, the Arthritis Advisory Committee recommending approval of Celltrion’s CT-P13. By finalizing guidances in areas such as biosimilar interchangeability, and by facilitating timeliness in biosimilar review and approval, the FDA has the opportunity to significantly impact our nation’s healthcare.

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