Diabetics to benefit under latest FDA biosimilar guidance
The Food and Drug Administration (FDA) has issued final guidance on the pathway for ‘interchangeable’ biosimilar products, in a bid to promote competition in the biologics market.
Ned Sharpless, commissioner of the FDA, released a statement on Friday, May 10, announcing the final guidance on a pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber.
Biosimilars are copies of biologic drugs where the active ingredient is made by an engineered organism, and promoting competition in the biosimilar space has been an ongoing project for the FDA.
Scott Gottlieb, former FDA commissioner, released the agency’s biosimilar action plan in July 2018, a four-part strategy aimed at strengthening sales of biosimilars.
This plan is part of the FDA’s blueprint to lower drug prices and facilitate the entry of generic and biosimilar drugs into the US market.
US Congress created an approval pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA approved biological brand (or reference) product in the Biologics Price Competition and Innovation Act of 2009.
“This pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, by increasing access to life-saving medications and potentially lowering health care costs through competition,” said Sharpless.
Last week’s guidance provides an overview of scientific considerations in demonstrating interchangeability with a reference product. It also explains the scientific recommendations for an application or a supplement for a proposed interchangeable product.
Sharpless added that the guidance was of particular importance to the millions of Americans with diabetes, as the guidance will help enable biosimilar or interchangeable insulin products to come to market in the future.
“For chronically used biologic medications patients get at the pharmacy, such as insulin, the ability to have a licensed interchangeable that can be substituted at the pharmacy without the intervention of the prescribing health care professional—much like how generic drugs are routinely substituted for brand name drugs—could be integral to the success of reducing drug prices for patients,” added Sharpless.
To date, the FDA has already licensed 19 biosimilar products.
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