In a letter dated May 21 to FDA Commissioner, Margaret Hamburg, the Society for Women’s Health Research (SWRA) along with over 40 other organizations, asked the FDA to consider gender disparities when it comes to biosimilars policies.
“As FDA finalizes critical policy issues relating to bringing the first biosimilars to market in the U.S. we ask that you give serious consideration to the impact of these policies on women’s health. Women are often underrepresented in clinical trials, and even when they are included clinical results are not routinely analyzed by sex. Accordingly, the long-term effects and adverse reactions of biologics on female patients is not known.
Distinguishable names will lead to better health outcomes for women by enabling the gathering of sufficient data to ultimately allow providers to fully understand how all biologics – including biosimilars – are performing for women.”
To view letter to the FDA click here.