Generic and biosimilar medications and multiple sclerosis
Generics and biosimilars are follow-on medications. A generic is a follow-on medication to a brand medication and a biosimilar is a follow-on medication to a biologic. They are determined by the U.S. Food and Drug Administration (FDA) to be bioequivalent to (the same as) or biosimilar to (functionally the same but not identical due to natural differences) the original medication.
Generics are bioequivalent to their brand name medication counterpart. Biosimilars are biosimilar to their biologic medication counterpart. Generics and biosimilars may offer additional treatment options and savings.
As explained by the FDA, a generic medication is created to be the same as a brand-name medication. It is equally safe and has the same dosage form, strength, quality and intended use. In other words, a generic medicine works in the same way and provides the same benefit as its brand-name version. You can take it as a substitute for the brand-name medication.
A generic medication can become available when a brand-name medication’s patent protections have ended. After a patent expires, manufacturers can apply for a license to manufacture and market generic versions of a medication.
Generic medications are often prescribed to help manage MS symptoms and other conditions. However, there are only a few FDA-approved generic disease-modifying therapies (DMTs) at this time. Some MS medications that currently have generics include Copaxone (glatiramer acetate, Glatopa), Gilenya (fingolimod), Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide).
The MS therapy landscape is continuously evolving. It is likely that more generic DMTs will become available to treat MS.
Biologics and biosimilar medications
Biological medications (biologics) are made from living sources (such as animal cells, plant cells, bacteria or yeast) through a complex biotechnological process rather than a chemical manufacturing process. The term for an equivalent medication of a biologic is “biosimilar” or “follow-on biologic.” Biosimilars are also made from living sources.
Biosimilars, like the originator biologics, will have natural differences even from batch to batch because they are made from living sources. These slight variations must fall within acceptable, predefined limits in order to ensure these variations do not result in any clinically meaningful differences and receive FDA approval. They are as safe and effective as the original biologic.
The FDA approval process for biosimilar medications is different from the process for generics. Many of the medications currently used to manage the MS disease course are considered biologics. As new biosimilar treatments for MS become available, these follow-on medications may provide more affordable options for people affected by MS.
For more information, view an FAQ about generic, biologic and biosimilar medications.