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Compliance In Focus
Posted by Emily Zetzer on Fri, Apr 17, 2020

Insulin Gains New Pathway and What This Means for Patients

Insulin Gains New Pathway III In a landmark move insulin, along with other biologic drugs transitioned to the biologics regulatory pathway as of March 23rd. This transition is groundbreaking for millions of Americans as incidence of diabetes increases and accessibility to affordable insulin has become a matter of life and death.

The new biologics pathway outlined in The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was created by Congress and carried out by the U.S. Food and Drug Administration (FDA).

The new licensure pathway allows the FDA to approve the use of products deemed to be biosimilar or interchangeable to an already approved (reference) biological product.

Biosimilars are biological products that are shown through comparative tests to be “highly similar” to FDA-approved biological products, with only minor structural differences, and demonstrate no meaningful difference in terms of safety and efficacy.

In an announcement earlier this year FDA Commissioner Stephen M. Hahn, M.D. explained: 

“Biologic drugs are often complex therapies that can be used to treat some of the most serious illnesses, including autoimmune diseases, rare genetic disorders and diabetes. Life-sustaining insulin products are biologics, but to date, there has been limited competition in the marketplace, resulting in fewer choices and higher prices for patients. This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace.”

The transition is a milestone for several important treatment as it allows biosimilar products to seek approval through this new pathway facilitating greater competition in the market and a potential reduction in healthcare costs. Typically in the U.S., biosimilar products’ market cost is 15-35% lower than the reference product.

While the biosimilars pathway was established to provide more treatment options and increase access to biologic products and potentially lower market prices, the pathway was created with a 10-year timeline leading to this regulatory transition to ensure stakeholders were able to prepare.

The FDA has also taken several actions to support marketplace for biological products for stakeholders and manufacturers. This included partnering with the Federal Trade Commission (FTC) to issue a joint statement to deter anti-competitive behavior, address false or misleading communications, support competitive practices and provide information to patients and healthcare workers. The FDA and FTC expressed that the current anti-competitive practices are slowing progress and are concerned with the negative impact of these practices on the public perception of the safety and efficacy of these biosimilar products.

Key Points for Patients:

  • Insulin and other biological medications will be transitioned to this new regulatory pathway
  • This should not impact access to medications that are transitioning
  • The transition should not impact the physical appearance or how medication is administered; however, overtime, there will be transition-related revisions to product labeling
  • Once biosimilar products are approved there may be changes with insurance and pricing/reimbursement due to the more competitive market
  • Currently approved insulin and biological medications will not be designated as interchangeable
  • Biosimilar and interchangeable products through this pathway will likely not be available before 2021

What are your thoughts on the approval of this new regulatory pathway for biologics? How do you think this will change the focus in industry?


photo credit: RJJ245 Dreamy Scotland via photopin (license)

Topics: Biologics, Insulin


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