After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
