On March 10, Celltrion announced receiving US marketing authorization from the FDA for its omalizumab biosimilar Omlyclo (omalizumab-igec). This is the first omalizumab biosimilar (reference product, Xolair) to receive US approval. The FDA also granted Celltrion the interchangeability designation for Omlyclo. Omalizumab is an anti-IgE antibody.   The approval was for all of the reference … Continue reading Celltrion Gains First Omalizumab Biosimilar Approval