In the next few weeks, FDA will announce its decision on Novartis’s Zarxio, a granulocyte-colony stimulating factor biosimilar to Amgen’s Neupogen.
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.
