World's first (official) biosimilar antibody goes to reumatoid arthritis

The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory officials worldwide it meant more uncertainty and unknowns about proper, global biosimilar guidelines, business intelligence provider GlobalData.

On July 23, 2012, South Korean biosimilar manufacturer CellTrion announced the approval of Remsima (CT-P13), a biosimilar antibody, by the Korean Food and Drug Administration. Remsima is a biosimilar version of Johnson & Johnson’s Remicade (infliximab) which was one of the first monoclonal antibody TNF inhibitors approved for the treatment of Rheumatoid Arthritis (RA).

Remsima is approved for several indications and will be marketed in Asia and South America by the end of the year. In Europe, CellTrion filed for market authorization with partner Hospira to launch Remsima under the name of Infectra. Interestingly, Remsima is only the first officially approved biosimilar antibody for RA therapy as Reditux, a MabThera biosimilar, was launched in India in 2007, but under unapproved biosimilar development guidelines. The first-ever approved biosimilar, Omnitrope (somatropin), arrived on the European market in 2006. Since then 14 more drugs across the drug classes of human growth hormone, granulocyte stimulating factor, and erythropoietin have been approved in the European Union, notes GlobalData.