FDA News

FDA transitions insulin to new regulatory pathway, opening door for more biosimilars

The FDA on Monday announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products, according to an agency statement.

Beginning today, a small subset of “biological products” approved under the Federal Food, Drug and Cosmetic Act, such as insulin and human growth hormone, will transition to being officially regulated as biological products, enabling these drugs to serve as the reference product for biosimilar or interchangeable drugs approved through the abbreviated licensure pathway.

As Healio previously reported, the FDA published a final rule Feb. 20 outlining the application process for the new pathway for biological products, including biosimilar insulins, as part of a larger effort to streamline the approval of more follow-on agents, spur competition and reduce costs. Prior to today, the FDA required any follow-on insulins to be approved under the abbreviated new drug pathway; they were not considered to be “biosimilar” because insulins were approved and regulated as chemical drugs.

“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 Federal Food, Drug and Cosmetic Act; now that the day has arrived,” Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said in the release. “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 FDA on Monday announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products, according to an agency statement.
Source: Adobe Stock

There are currently two biosimilar insulins approved under the old pathway in the U.S. — Basaglar (Lilly), a follow-on to insulin glargine (Lantus, Sanofi) approved in 2015, and Admelog (Sanofi), a follow-on to insulin lispro (Humalog, Lilly) approved in 2017.

Historically, it was more difficult to develop generic versions of insulin and other biologic drugs under the Federal Food, Drug and Cosmetic Act due to scientific challenges and limitations on the scope of data that can be relied on in a generic drug application, according to the FDA.

The agency called today’s formal transition a “landmark moment” for people with diabetes.

“This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients,” Abernethy and Woodcock stated in the release. “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.”

In preparation for the transition, the FDA took several steps during the past 6 months, such as partnering with the Federal Trade Commission to address false or misleading statements and promotional communications by biologic product manufacturers, deter anticompetitive business practices and support a competitive marketplace for biosimilars. The agency issued a final rule, draft guidance and final guidances to provide clarity to industry and information for patients and health care providers about the transition.

In guidance for patients published online Monday, the FDA noted that the transition is a regulatory action in which the approved drug application for a transition biological product will be “deemed” to be a biologics license application. The transition will not change how patients’ medications appear, or how health care providers prescribe or dispense their prescriptions.

“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,” Abernethy and Woodcock stated in the release. “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 development, review and approval of these medicines.” – by Regina Schaffer

Reference:

FDA. Information for patients about regulatory changes for certain biological product medications. Available at: https://www.fda.gov/media/135341/download?utm_campaign=032320_Statement_Insulin%20Gains%20New%20Pathway%20to%20Increased%20Competition&utm_medium=email&utm_source=Eloqua. Accessed: March 23.

Disclosures: Abernethy is principal deputy commissioner of the FDA. Woodcock is director of FDA’s Center for Drug Evaluation and Research.

The FDA on Monday announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products, according to an agency statement.

Beginning today, a small subset of “biological products” approved under the Federal Food, Drug and Cosmetic Act, such as insulin and human growth hormone, will transition to being officially regulated as biological products, enabling these drugs to serve as the reference product for biosimilar or interchangeable drugs approved through the abbreviated licensure pathway.

As Healio previously reported, the FDA published a final rule Feb. 20 outlining the application process for the new pathway for biological products, including biosimilar insulins, as part of a larger effort to streamline the approval of more follow-on agents, spur competition and reduce costs. Prior to today, the FDA required any follow-on insulins to be approved under the abbreviated new drug pathway; they were not considered to be “biosimilar” because insulins were approved and regulated as chemical drugs.

“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 Federal Food, Drug and Cosmetic Act; now that the day has arrived,” Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said in the release. “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 FDA on Monday announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products, according to an agency statement.
Source: Adobe Stock

There are currently two biosimilar insulins approved under the old pathway in the U.S. — Basaglar (Lilly), a follow-on to insulin glargine (Lantus, Sanofi) approved in 2015, and Admelog (Sanofi), a follow-on to insulin lispro (Humalog, Lilly) approved in 2017.

Historically, it was more difficult to develop generic versions of insulin and other biologic drugs under the Federal Food, Drug and Cosmetic Act due to scientific challenges and limitations on the scope of data that can be relied on in a generic drug application, according to the FDA.

PAGE BREAK

The agency called today’s formal transition a “landmark moment” for people with diabetes.

“This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients,” Abernethy and Woodcock stated in the release. “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.”

In preparation for the transition, the FDA took several steps during the past 6 months, such as partnering with the Federal Trade Commission to address false or misleading statements and promotional communications by biologic product manufacturers, deter anticompetitive business practices and support a competitive marketplace for biosimilars. The agency issued a final rule, draft guidance and final guidances to provide clarity to industry and information for patients and health care providers about the transition.

In guidance for patients published online Monday, the FDA noted that the transition is a regulatory action in which the approved drug application for a transition biological product will be “deemed” to be a biologics license application. The transition will not change how patients’ medications appear, or how health care providers prescribe or dispense their prescriptions.

“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,” Abernethy and Woodcock stated in the release. “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 development, review and approval of these medicines.” – by Regina Schaffer

Reference:

FDA. Information for patients about regulatory changes for certain biological product medications. Available at: https://www.fda.gov/media/135341/download?utm_campaign=032320_Statement_Insulin%20Gains%20New%20Pathway%20to%20Increased%20Competition&utm_medium=email&utm_source=Eloqua. Accessed: March 23.

Disclosures: Abernethy is principal deputy commissioner of the FDA. Woodcock is director of FDA’s Center for Drug Evaluation and Research.