The world’s first (official) biosimilar antibody goes to … rheumatoid arthritis

On 23 July, 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 authorisation with partner Hospira to launch Remsima under the name of Infectra.

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 (EU).

The definition of a biosimilar drug is, according to the World Health Organization, a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Guidelines to maintain the safety and efficacy of these drugs have been difficult to draft and approve worldwide. The issues which have come under scrutiny include questioning of the biosimilar formulation, the amount of clinical trial data needed and quality control of manufacturing practices.

Without a global resolve and understanding of the clinical and regulatory factors involved in designing and marketing a biosimilar drug, the market uptake will likely be slow. However, it is estimated that the biosimilar market will reach close to $4 billion by 2017.