Decision Resources forecasts biosimilar insulins and insulin analogues to erode $6.1 billion in brand sales

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, forecasts that biosimilar insulins and insulin analogues stand to erode $6.1 billion in brand sales in the U.S. and Europe (France, Germany, Italy, Spain and U.K.) by 2018, saving healthcare systems $3.8 billion in the process.

As insulins are relatively easy to develop and manufacture, the new special report entitled Biosimilars: ESAs, Insulins, and Human Growth Hormones, predicts that a number of competing long-acting biosimilar insulins, which are typically injected once or twice daily, will enter the market during the 2008-2018 study period. Based on differences in revenue and upon patent expiry, Sanofi-Aventis' Lantus presents a greater opportunity for manufacturers of biosimilars than Novo-Nordisk's Levemir.

"Our survey data suggests that most endocrinologists expect to begin prescribing biosimilars within a year after they launch. Although endocrinologists will require a fair amount of clinical data before they will be comfortable prescribing biosimilars, they have fewer reservations about using biosimilar insulins (used in patients with diabetes) than they do for biosimilar human growth hormones (used in patients with human growth hormone deficiency)," stated MaryEllen Klusacek, Ph.D., analyst at Decision Resources.

The report also finds that although surveyed nephrologists have an overall conservative attitude towards biosimilar use, they are not completely opposed to prescribing a biosimilar for an indication in which it has been approved, but not clinically studied. Based on EMEA guidelines and proposed legislation in the United States, biosimilars will be labeled for each indication for which the reference product is labeled, even if the biosimilar is only clinically studied in one indication. For example, while Johnson & Johnson's Procrit/Eprex is approved for and used in the treatment of chronic renal failure and chemotherapy induced anemia, its biosimilar may only be studied in chemotherapy induced anemia, yet get approved for all of the indications that Procrit/Eprex is approved for.

"In order to head off competition from biosimilars that need additional validation, makers of branded biologics should create marketing campaigns focusing on their agents' proven safety and efficacy," added Dr. Klusacek.