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.

SOURCE Decision Resources