GP2013: A Rituximab Biosimilar.

GP2013 is the second biosimilar of the reference monoclonal anti-CD20 antibody rituximab to be approved in the EU. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. GP2013 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA. GP2013 demonstrated clinical efficacy equivalent to that of reference rituximab in patients with FL, and was generally well tolerated in this population. The tolerability, immunogenicity and safety profiles of GP2013 were similar to those of reference rituximab. The role of reference rituximab in the management of cancers and autoimmune conditions is well established and GP2013 provides an effective biosimilar alternative for patients requiring rituximab therapy.