FDA biosimilar draft guidance creates drug delivery leeway
Biosimilar drug developers will potentially gain some drug delivery leeway, according to proposed draft guidance issued by the FDA.
Regulators released the long-awaited draft guidance last week that would shape how all kinds of biosimilar drugs are tested and manufactured. And as In-pharmatechnologist.com reports, the lengthy documents contain a small question-and-answer section that appears to suggest some flexibility toward drug delivery approaches for biosimilar drugs.
For example, the original drug may have been sold in a vial, but the manufacturers could choose to market the biosimilar version as part of a pre-filled syringe or auto-injector device instead. The key? They'll have to supply studies that show that the added device or delivery mechanism is compatible with the biosimilar drug.
The FDA will also want to know if an added delivery system/device creates too much work for patients or providers, according to the article. A change that's too drastic, in other words, risks regulatory rejection. What's more, certain delivery technology additions may lead the FDA to consider the biosimilar drug to be a combination product. That means companies would need to file a separate application and work through more regulatory hurdles, the article notes.
What does this mean for biosimilar manufacturers? Assuming the draft guidance becomes official, there is enormous opportunity for them to compete with the original drug by adding a delivery syringe, auto-injector or something similar that makes it unique. And if that addition makes the drug easier to use, then compliance rises and their product gains market share. But they should not try to be too bold, because there will likely be many regulatory rat traps that trigger unexpected hurdles.
FDA maps out long-awaited rules for the biosimilars business