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Evolving Complexity of Biologics Space


Dr Karara discusses evolution of the biologics space and highlights important regulatory definitions.

Kareem Karara, PharmD, BCPS, CCHP: The biologic space has changed dramatically over the last decade. It used to be that once a drug was a biologic, there was no way to have a competitor product for that medication. The introduction of a biosimilars approval pathway in 2010 was a game-changer. It offered manufacturers an opportunity to create similar therapeutically equivalent medications to medications that were only available as brands, so we had some biosimilars in the following years. Regarding the introduction of interchangeable biosimilars, it was an even bigger deal we have an opportunity to substitute and increase adoption of biosimilar medications.

One of the challenges with biosimilars is the need for providers to write a medication order for the biosimilar product as opposed to the reference product. Well, an interchangeable biosimilar removes that hurdle with the goal of improving the adoption of biosimilars in the marketplace. And then, unbranded biologics, the latest innovation, offer the most promise. These medications are essentially the innovator products, without the innovator name. With interchangeable biosimilars and unbranded biologics we now have 2 options to substitute for the branded products with a goal of improving adoption.

To define what an unbranded biologic is and more specifically how the FDA defines it, I'd like to use an analogy. There is a recurring article that pops up on the internet every few months that lists Costco's store-brand Kirkland Signature products that are actually made by the same retail titans who manufacture branded products: store-brand coffee that is custom-roasted by Starbucks, or batteries that are manufactured by Duracell. Essentially, they are the same thing in different packaging. I think of unbranded biologics the same way. An unbranded biologic is considered by the FDA to be equivalent to its brand-name biological product because it is the same product as the brand-name biological product under the same BLA. The term "unbranded biologic" or "unbranded biological product" generally describes an approved brand-name biological product that's marketed under its approved BLA without its brand name on its label.

Transcript edited for clarity.

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