Biologics are truly innovative therapies, but they are extremely expensive. The development of biosimilar medicines is an emerging field that is generating high levels of interest within industry, and offers the prospect of increasing patient access to these highly effective medicines. Currently, the global biosimilars market includes monoclonal antibody (mAb) biosimilars for the treatment of cancer and autoimmune conditions (e.g., rheumatoid arthritis), as well as insulins, interferons, erythropoietin, filgrastim, somatropin and follicle stimulating hormone. Of these, the mAb and insulin markets are forecast to record the highest growth rates, with these two segments representing a projected 46% of the global biosimilars market by 2018, by which time many leading brands will have lost their patents. As a result of these pending patent expiries, the biosimilar clinical trial industry is booming. Reports vary, but the number of biosimilar candidates in the global pipeline appears to be around 900: however, only 305 are in clinical trials. The time and financial investment needed to develop and market a biosimilar is high, taking seven to eight years and costing between $100 million and $250 million.
Article March 11, 2015