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Frequently Asked Questions: Generic and Biosimilar - Medications


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What is a generic medication?

A generic medication is a product that is equivalent to a brand-name medication whose patent protections have expired.

As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.

Manufacturers are required to show that the generic medication delivers the same amount of active ingredients to the person’s bloodstream in the same amount of time as the brand-name product—referred to as bioequivalence. 
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Do generic medications have the same therapeutic benefit as name-brand medications?

The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic medications to brand name medication products. If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.

The FDA is empowered by Congress to evaluate generic medication candidates through Abbreviated New Drug (Medication) Applications
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Will there be equivalent medications for all MS therapies?

It’s possible that eventually there will be. Before any medication may be copied, the patents protecting the brand-name medication must expire. Then a maker of equivalent medications would need to apply to the FDA with a request for approval of its medication.

The term generic technically applies to products that are considered medications made through a chemical manufacturing process. MS therapies that currently have generics available include Copaxone (glatiramer acetate, Glatopa), Gilenya (fingolimod), Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide). The other MS therapies are technically classified as biologics or biological products. 
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What’s the difference between generics and biologics?

The term generic technically applies to medications made through a chemical manufacturing process. Production of generic medicines is reasonably straightforward: the active substance in the generic medicine is identical to the active substance within the original brand.

Biologics are generally more complex, and they are made from human or animal materials rather than chemical processes. The technical term for an equivalent medication for a biologic is biosimilar or follow-on biologic.
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How are biosimilar products evaluated by the FDA?

The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form and strength as the reference product. Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product. Under a law passed in 2009, a biological product may be demonstrated to be biosimilar if data show that:
  • the product is highly similar to the already-approved biological product;
  • it has no clinically meaningful differences in terms of safety, purity and potency from the reference product;
  • the proposed biosimilar is expected to produce the same clinical result. 
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What is the current progress toward developing equivalent medications for MS therapies?

The FDA has approved three generic forms of glatiramer acetate (as of 2019), and the agency has received Abbreviated New Drug Applications for other generic forms of this medication. No other disease-modifying MS medications are available in a generic form.  
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Where can I get more information about generic medications and biosimilars?

The FDA’s website has information about generics and biosimilars and processes for their approval.


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