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FDA releases new patient guidance on biosimilars Posted 11/10/2019

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

The materials, ‘Biosimilar Basics for Patients’, explain that biosimilars are ‘FDA-approved biologic[al] medications that are compared to […] the original biologic[al]’ and are safe and effective.

The guidance also links to a separate information sheet called ‘What is a Biosimilar?’ which explains in more detail what a biosimilar is, and states that biosimilars have no clinically meaningful differences from the reference product and are only approved by FDA following rigorous testing.

The materials attempt to ease patient concerns by explaining that biosimilars offer the same benefits and risks as the reference biological; provide patients with more access to improve important treatments; and are as safe and effective as the original biological.

The materials also answer a number of frequently asked questions, on topics including what biological drugs are, what biosimilars are, and the difference between biosimilars and generics.

The resources also address cost differences between reference biologicals and biosimilars. The document explains that biosimilars can reduce costs, however, FDA itself does not regulate whether insurance companies will cover or reimburse costs. It recommends that patients check with their insurance providers or, for patients covered by Medicare or Medicaid, the Centers for Medicare & Medicaid Services. If a patient wants to know if they are being prescribed a biosimilar, the guidance recommends talking to their healthcare provider or pharmacist.

The guidance also addresses switching (from reference to biosimilar), stating that ‘generally, biosimilar medications can be used whether or not you have been treated first with the reference product.’ However, it also recommends talking to a healthcare provider about ‘potential risks’.

An accompanying infographic highlights the same key points that biosimilars are FDA-approved medicines that provide the same treatment benefits as the original biological; are safe and effective; and increase patient access.

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Source: US FDA

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