Insulin Gains New Pathway to Increased Competition

The U.S. Food and Drug Administration reports today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.

Biologic drugs, including insulin, treat some of the most serious diseases and conditions. The drugs transitioning today are used in the treatment, diagnosis, and prevention of many of these conditions, including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more. But these life-saving drugs often also contribute significantly to drug costs. Historically, it was more difficult to develop generic versions of these drugs under the Federal Food, Drug and Cosmetic (FD&C) Act due to scientific challenges and limitations on the scope of data that can be relied upon in a generic drug application. This framework contributed to limited competition for these drugs, resulting in fewer choices and higher prices for patients. Today’s transition opens a new pathway for manufacturers to seek FDA approval of and bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition.

When Congress created the biosimilars pathway in the Biologics Price Competition and Innovation Act of 2009, Congress also created a 10-year timeline for stakeholders to prepare for the regulatory transition of biological products that were historically regulated under the FD&C Act; now that the day has arrived, the FDA can begin receiving applications for proposed biosimilars to these licensed transition biological products, including insulin products that millions of Americans rely on every day to maintain stable blood glucose. Approved biosimilars will be able to come to market, where there is incredible potential to reduce health care costs, as has been seen with increased generic drug offerings. On the generic drugs’ side, we know from an FDA analysis that even with one generic on the market, prices are 31 to 39% lower than before the generic competition. Similarly, biosimilars marketed in the U.S. typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products.

Over the last 10 years, the FDA has worked hard to establish a strong framework for the biosimilar and interchangeable regulatory pathway, as well as providing clarity to all involved on what the transition means to them and how it may affect our many stakeholders. Our  Biosimilars Action Plan was established to improve the efficiency of the biosimilar and interchangeable product development and approval process and to maximize scientific and regulatory clarity for the biosimilar product development community. Through this action plan, we’ve worked to support robust competition from biosimilars, including supporting market competition and providing clear direction to industry on many relevant topics leading up to the transition.

In just the last six months, we’ve taken several important actions on biosimilars, and in preparation for this transition, including partnering with the Federal Trade Commission regarding efforts to address false or misleading statements and promotional communications by biologic product manufacturers, deter anti-competitive business practices and support a competitive marketplace for biosimilars; issuing a final rule, draft guidance and final guidances to provide clarity to industry; providing information for patients and health care providers about what the transition means to them; and expanding and digitizing the FDA’s database of FDA-licensed biological products, otherwise known as the Purple Book.

These actions, among the many others we’ve taken in this space, reflect the tireless work of our dedicated workforce to ensure a smooth regulatory transition and provide clarity for biosimilar developers. We stand ready to review incoming applications from industry. We will also continue to work closely with those interested in producing biosimilar and interchangeable products to support efficiency in the development, review, and approval of these medicines.

Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.

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