The Association of Clinical Research Organisations (ACRO), which claims to represent firms conducting trials in 115 countries worldwide, made the recommendations in a letter sent to the US Senate.
The approval of biosimilars, or generic versions of biologic drugs, is currently a topic of hot debate in the US with the main focus of argument being the length of the market exclusivity period awarded to such medications.
However, in a letter sent yesterday, the ACRO raises the issue of trials, with a specific focus on patient safety.
The organisation said that: “While the data exclusivity period is of great importance, we view the approval process for biosimilars to be of at least equal importance and the statutory pathway for approval should not be overlooked in the legislation to reform the US health care system.”
The ACRO recommends that clinical testing be required for the approval of all biosimilars unless the Food and Drug Administration (FDA) waives such trials and advises that the same efficacy, purity and immunogenecity standards required of innovator drugs be demanded of all generic biologics.
It also believes that “the data requirements for approval of a biosimilar may be reduced if there is a scientific basis to do so but the data quality must be at the same level as the innovator product and patient welfare must not be compromised.
The ACRO’s executive director, Doug Peddicord, stressed that: ”Patient welfare must remain paramount and the only way to ensure effectiveness and safety for the patient is through rigorous clinical testing and ongoing evaluation.”
Dr Peddicord added that: “We urge that our recommendations be incorporated into the final legislative language or the committee reports that accompany any biosimilars legislation.
The full ACRO letter can be read here.