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Generic and Biosimilar - Medications

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Overview

Generic, biologic and biosimilar are all terms for non-brand medications (also known as a drug or therapy) determined by the US Food and Drug Administration (FDA) as equivalent to (the same as) the brand medication.

Generic medications

According to the FDA, a “generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.”

A generic medication can become available when a brand-name medication’s patent protections have expired. Generic versions of branded medicines have been around for a long time, as has the process through which generics are introduced to the market: the original brand product has a finite patent life, at the end of which other manufacturers can apply for a license to manufacture and market a generic version

Generic medications are often prescribed to help manage MS symptoms, however, there are only a few FDA-approved generic disease-modifying therapies at this time. The MS therapy landscape is continuously evolving and it is likely that more generic disease-modifying therapies will become available to treat MS. 

Biologics and biosimilar medications

Biological medications (biologics) are made from human or animal materials (complex biotechnological process) rather than through a chemical manufacturing process. The technical term for an equivalent medication for a biologic is biosimilar or follow-on biologic. Many of the medications currently used to manage the MS disease process are considered biologics. The FDA approval process for biosimilar products is different than the process for generic medications. Learn more about biologics on the FDA website.

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