Insulin, other biologics gain new pathway for biosimilars
The FDA expects that the regulatory transition, mandated by Congress, will support market competition and increase patient access to these drugs.
Insulin and certain other biologic drugs have a new pathway for biosimilar or interchangeable products, the FDA announced on March 23.
The regulatory transition, mandated by Congress and implemented by the FDA, will for the first time allow manufacturers to apply for proposed biosimilars to these products, facilitating greater competition, the FDA said. Historically, it was more difficult to develop generic versions of these biologic drugs under the Federal Food, Drug, and Cosmetic Act, the FDA noted. The therapies to which this new policy applies are used for many conditions, including diabetes, respiratory distress syndrome, fertility conditions, Cushing's syndrome, deep venous thrombosis, and Gaucher disease.
“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,” the FDA said.