FDA institutes shortened approval pathway for biosimilars

The Food and Drug Administration has instituted a shortened regulatory pathway for certain biologics, including insulin and human growth hormone, that have previously been classified as drugs.

The agency will consider future marketing applications for these products as biologics license applications which will allow for faster approvals compared to the generic drug pathway while promoting increased competition.

Amy Abernethy, principal deputy commissioner, at the Food and Drug Administration, and Janet Woodcock, director of the Center for Drug Evaluation and Research issued a joint statement outlining the new pathway that was mandated by Congress. 

"For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products," the statement said. "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 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.

Abernethy and Woodcock explained that these life-saving drugs often also contribute significantly to drug costs, and that it was more difficult to develop generic versions of these drugs under the Federal Food, Drug and Cosmetic 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,” the statement said.

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," the statement said. "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 United States typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products."