On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab)....more
On December 3, 2024, Accord BioPharma, Inc. (“Accord”), the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas”), announced an agreement to acquire Coherus BioSciences, Inc.’s UDENYCA® (pegfilgrastim-cbqv)...more
On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), for the...more
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™...more
On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more