FDA Move Opens Door to Biosimilar Insulins, Other Biologics

Miriam E. Tucker

March 24, 2020

The US Food and Drug Administration (FDA) has now officially changed the way it regulates insulin and other biologics to facilitate approval for biosimilars.

As of March 23, 2020, insulin and other biologics such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins will be regulated by the FDA as biological products rather than drugs.  

This means that any insulin (or other biologic) currently approved as a so-called "follow-on" will now be deemed a biosimilar and will be interchangeable with the branded products.

Healthcare providers will be able to find these products in the "Purple Book" rather than the "Orange Book" from which they will be removed.

This 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," said Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research.

The move was mandated by the Biologics Price Competition and Innovation Act of 2009, which created a 10-year window to prepare for the transition of biological products previously regulated under the Federal Food, Drug, and Cosmetic (FD&C) Act to the Public Health Service Act.

Unclear to What Extent Change Will Help Lower Prices

The insulin products Basaglar (insulin glargine) and Admelog (insulin lispro) are currently called "follow-on" biological products in the United States and were approved through an abbreviated pathway under the FD&C Act.

As such, they're not "interchangeable" with the brand-name products Lantus and Humalog, so pharmacists can't simply substitute them without the physician writing a new prescription.

"Now, it is possible for manufacturers to submit, and the FDA to approve, marketing applications for biosimilar and interchangeable biological products that reference transitioned biological products, which will help drive competition in the market, and patients may have more affordable access to the medications they need," FDA spokesperson James McKinney told Medscape Medical News.

It's not yet clear to what extent the move will lower prices. Although the presence of even a single generic drug typically lowers the price of a compound by 31% to 39%, biosimilars marketed in the United States typically have launched with initial list prices from just 15% to 35% lower than comparative list prices of the reference products, according to an FDA statement.

In a notice to healthcare providers, FDA says that the currently marketed "transitional" biological products have now been removed from the Orange Book (the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations) and added to the Purple Book (the FDA's List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations).

"Beginning on or shortly after March 23, 2020, healthcare providers can find transition biological products in the Purple Book, which identifies licensed biological products by brand name and nonproprietary name," the agency said.

Nothing will change about the products themselves, or how they're prescribed or used.

Information for patients can be found here.

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