Published on October 15, 2009 at 12:51 AM
The Association of Clinical Research Organizations has called on Congress to ensure that any biosimilars legislation it passes requires clinical testing to ensure patient safety, efficacy, purity and potency. ACRO’s recommendations were included in a letter to the congressional committees with jurisdiction over health care policy.
“While much of the debate around biosimilars has centered on the data exclusivity period, our members, as researchers, are more focused on ensuring that the regulatory pathway for approval makes certain that patient welfare is the primary concern and that comparative efficacy is clearly demonstrated,” said Doug Peddicord, Ph.D., Executive Director of ACRO. “The only way to ensure effectiveness and safety for the patient is through rigorous clinical testing, high standards for data quality, and ongoing evaluation.”
Peddicord added that ACRO supports a data exclusivity period of 10-to-12 years for innovators in order to ensure an adequate return on investment, to attract new capital and to encourage continued research and development of breakthrough life-saving and life-enhancing biologics.
Source: Association of Clinical Research Organizations