Are Brand-Name Generic Drugs Safe and Effective?

Tim Gentilecore

Generic drugs are all about saving money. Tim Gentilcore, PharmD, head of Mission Health Pharmacy, answers common questions so you can decide if it’s worth it.

Q: What is a generic drug?

A: A generic drug is a “bioequivalent” of a brand-name drug. Bioequivalent is a fancy way of stating that the drug will have a biologically equal impact on your body as a brand-name product. All generic drugs are required to meet FDA requirements to ensure the safety and efficacy of the product, and additionally, they have to display bioequivalence to their brand-name competitor.

Q: Why would I want to take a generic if the brand-name product is available?

A: Generic drugs are almost always cheaper—extremely staggering in some cases—than the brand-name equivalents. Due to the price differences insurance companies prefer to pay for generic medications, they often will not cover any of the cost of a brand-name medication when a generic competitor is available.

Q: What if my new generic medication looks nothing like the brand name?

A: Generic companies will often try to make their product look comparable to a brand-name competitor, but sometimes they will look very different. Generic drug makers are not required to use the same coloring agents and inactive ingredients. This means that there can be differences in how the drug is produced, but it must always still meet the bioequivalence standards set by the FDA.

Q: What if I don’t want a generic product?

A: As a patient, you should always have this choice, however, you will likely have to pay significantly more for your drug if there is a generic competitor.

Q: Are there any specific situations where a generic might not be used even if it is available?

A: Yes. There is a small group of drugs referred to as narrow therapeutic index drugs—NTIs for short. These drugs include commonly prescribed agents like warfarin, levothyroxine, carbamazepine and others. These drugs are so specific in regards to their dosing and how your body reacts to that dosing, that even the slightest changes can have significant biological impacts. For this reason many states, including North Carolina, have a specific list of these drugs that cannot be substituted unless both you and your doctor say it is okay.

Q: Is a “biosimilar” drug the same as a generic drug?

A: Generic drugs are copies of brand-name drugs. Manufactured through biotechnology, biosimilar drugs are similar to, not copies, of them. Biosimilar drugs must be similar to the originals in terms of effectiveness and safety, and they are approved by the FDA.

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Tim Gentilcore, PharmD, is the Director for Mission Health’s Retail Pharmacy

By Tim Gentilcore