posted by Kristine Grow
on December 12, 2018
WASHINGTON, D.C. – Matt Eyles, president and CEO of America’s Health Insurance Plans (AHIP), issued this statement following the Food and Drug Administration’s (FDA) release of guidance documents on the development of biosimilar and interchangeable products and on the transition of products like insulin from its status as a small-molecule drug to a biologic , which clears a path for the introduction of more competition in the market:
“Drug prices are out of control, putting essential medications out of reach for too many American families. We appreciate the Administration’s continued commitment to lower drug prices for consumers with solutions that promote competition, affordability, and choice.
“Biologics are essential to good patient care, and insulin is critical for more than 29 million Americans who are diagnosed with diabetes. But medications offer no relief if patients cannot afford them. New guidance issued today by the FDA takes great strides to remove barriers to more competition for expensive branded biologics, and provide much-needed clarity on the interchangeability between biologics and biosimilars.
“This new FDA guidance ensures that branded manufacturers cannot abuse FDA safety protocols to limit access to supplies of biologic products and avoid lower-priced biosimilar competition. It also clears the way for biosimilar competitors to life-saving insulins, where manufacturers have faced no generic competition for almost a century and increased prices by almost 600 percent since 2001. This new guidance reflects precisely the kinds of solutions needed to sustainably drive down drug prices while encouraging competition and innovation for all Americans.
“We thank Commissioner Gottlieb and Secretary Azar for their leadership. We will continue to advocate for federal and state policies that increase competition among drugs and biologics to reduce prices. By working together, we can ensure that patients are able to get the therapies they need at a cost they can afford.”