More than seven million diabetics rely on daily insulin injections to maintain glycemic control and reduce the risk of life-threatening complications including heart disease, organ failure, and blindness. But access to this critical drug has become increasingly difficult for Americans because the price of insulin increases by double digits year over year.

“As a society, we must ensure that everyone who need insulin has access,” said Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb in a news release.

The FDA is engaged in a comprehensive approach to driving down drug prices, Gottlieb said. One approach is through healthy competition. “This is particularly true following the introductions of generics, especially when there are three or more generic competitors – which has been shown to bring down prices more sharply than with only one or two generic competitors.”

One way the FDA hopes to achieve this goal is through implementing a pathway for approval of biosimilar and interchangeable insulin products, which would open biologics to competition and ultimately provide patients with more treatment options while potentially lowering health care costs.

Biosimilars are biologic medical products that are almost identical to an original product that is manufactured by a different company. Biologics are typically isolated from a variety of natural sources – human, animal or microorganism. But because of their many complexities, it has been difficult for the FDA to bring a substitutable generic insulin to the market under previous regulations. Transitioning insulin from the drug to the biologic pathway will open these products to biosimilar competition.

“Transitioning biological products currently regulated as drugs to being regulated as biologics will enable – for the first time – products that are biosimilar to, or interchangeable with, these products to come to market,” Dr. Gottlieb said. “The FDA can play an important role in encouraging competition by implementing a robust pathway for biosimilar competition.”

On May 13, the FDA will hold a day-long public meeting to discuss access to insulin and issues regarding development and clearance of competitor products, including biosimilars and interchangeable insulin products. Dr. Gottlieb says he hopes to hear from patients, families, health care providers and others who live with diabetes or are caregivers to diabetics about their challenges as the agency prepares for submissions and review of biosimilar and interchangeable insulins.

“American patients who rely on insulin to live deserve to have high-quality, affordable options. The FDA is dedicated to facilitating access to insulin,” Gottlieb said.

Source: FDA News Release

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