Barriers to US market entry for biosimilars continue

As a result of biosimilars slow entry into the US market, the Food and Drug Administration is taking proactive measures to ensure the continued growth of the biosimilars market by educating patients and physicians through online resources and information campaigns to encourage more competition and lowered prices of biologics, according to data and analytics company GlobalData.

Despite the FDA implementing the Biologics Price Competition and Innovation Act (BPCIA) in 2010 to create an abbreviated pathway for biosimilar drug approval, there are only nine biosimilars available on the US market to date and it is estimated that only 3% of spending on biologics may face competition from biosimilars, according to The New England Journal of Medicine.

A superficial detail that presents an educational barrier is the recent biosimilar naming system employed by the FDA. They require the biosimilar to include the non-proprietary name and a suffix that identifies the manufacturer in order to improve pharmacovigilance, but this results in confusion for physicians and patients who might be led to believe that the clinical effects of the biosimilar differ from the original product.