Differentiating Between Unbranded Biologics and Biosimilars


Differences between biologics – both branded and unbranded – and biosimilars are explored by Dr Karara.

Kareem Karara, PharmD, BCPS, CCHP: An interchangeable biosimilar is a biosimilar that can be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. An interchangeable biosimilar is a biologic product that’s biosimilar to the reference product. It can be expected to produce the same clinical result as the reference product in any given patient. For products that are administered more than once—chronic therapies—the risk in terms of safety or diminished efficacy in alternating or switching between the product and its reference product isn’t any greater than the risk of using the reference product without switching at all. For an interchangeable biosimilar, the FDA is going to require specific switch studies to show that it’s interchangeable.

An unbranded biologic differs from a biosimilar in the following ways: An unbranded biologic is essentially a branded biologic without the brand name on the label, but a biosimilar is different. A biosimilar is highly similar to the reference product, the branded biologic, notwithstanding any minor differences in clinically inactive components of the medication. There are no clinically meaningful differences between the biologic product and the reference product in terms of safety, purity, and potency.

Transcript edited for clarity.

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