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FDA Officials Predict More Insulins Under New Biologics Pathway


Competition in the insulin market is expected to rise because insulin products will be approved under the regulatory pathway for biological products now that the transition period added to the Biologics Price Competition and Innovation Act (BPCIA) of 2009 has officially ended, the FDA said.

New insulin products are officially being approved under the biologics regulatory pathway, which will allow for an increase in patient access and market competition for biosimilar versions, the FDA said in a statement, calling this a “historic day.”

“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,” said the statement, which was authored by Amy Abernethy, MD, PhD, principal deputy commissioner, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research.

A 10-year transition built into the Biologics Price Competition and Innovation Act (BPCIA) of 2009 allows for the biologics pathway approval of several types of agents, including insulin and certain other drugs originally classified as small-molecule drugs, that were previously regulated under the Food, Drug, and Cosmetic Act.

Under the new pathway, “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,” the statement said.

An analysis conducted by the FDA revealed that US marketed biosimilars typically launched with 15% to 35% lower initial list prices than comparative list prices of reference products. Additionally, even with only 1 generic on the market, list prices can drop by 31% to 39%.

Historically, the old regulatory pathway was much more difficult for the development of generic versions of these drugs due to scientific challenges and limitations on the scope of reliable data in a generic drug application.

The FDA noted that the former “framework contributed to limited competition for these drugs, resulting in fewer choices and higher prices for patients.” The new change also will allow manufacturers to seek FDA approval for biosimilar and interchangeable versions of insulin and other transitioning products, leading to greater competition for the market.

In addition to the transition, the FDA also created the Biosimilar Action Plan, which was established to improve the efficiency of biosimilar and interchangeable product development and to maximize scientific and regulatory clarity for biosimilar development stakeholders.

“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,” the FDA said.

Another action the FDA has taken to boost the US biosimilar market is partnering with Federal Trade Commission, which addresses false or misleading statements or promotional content by biologic product manufacturers to deter competing biosimilar products from entering the market.

The FDA has also issued a final rule, draft guidance, and final guidance to provide clarity to the biosimilar industry; provided information to patients and healthcare providers about the impact the transition will have; and digitized the Purple Book, an FDA database the lists licensed biological products, to make searching easier.

“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,” the FDA noted.

Biologic and biosimilar drugs, including insulin products, are used to treat some of the most serious diseases and conditions including diabetes, respiratory distress syndrome, fertility conditions, Cushing syndrome, deep vein thrombosis, Gaucher disease and more.

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