MedCity News June 20, 2024
Frank Vinluan

FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching studies add time and expense to the development of biosimilars, delaying them from reaching patients.

The FDA is considering a change in biosimilar policy that could make things a lot easier for a whole host of stakeholders that include the companies that develop these complex follow-on biologic drugs, the clinicians who prescribe and dispense these medications, and the patients who receive them.

Right now, when a patient goes to a pharmacy to fill a prescription for a complex biologic, the pharmacist can’t substitute a lower-cost biosimilar unless the FDA has classified that drug...

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