You have a bacterial infection and your doctor fills out a prescription for an antibiotic. When you arrive at the pharmacy, you notice you have two choices. You can buy the generic version or the name brand.
The name brand cost twice as much.
So what should you do? You would love to save the money and go with the generic, but at the same time, you're not sure if you can trust it.
In this article we will give you insight into generic vs brand name drugs, and what you should do next time you have a choice.
Generic vs Brand Name Drugs
When a drug comes into the market in the United States, its parent company can sell it exclusively under a brand name for a certain number of years. This length of time depends on how many years are left on the drug patent and the type of exclusivity it's granted by the FDA.
Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.
When the patent or exclusivity runs out, other companies can begin making a generic version. The generic brands are usually cheaper than the name brand drugs.
In America cheaper usually means not as good of quality- right?
Sometimes, yes. But that's not always the case when dealing with pharmaceuticals.
Quality of Generic Drugs
Before a generic drug can be marketed by a company, it must submit an Abbreviate New Drug Application to the FDA. The application includes that the generic drug is two important things.
It includes that it is pharmaceutically equivalent in comparison to the name brand version. And it includes that it is bioequivalent in comparison to the name brand version.
Pharmaceutical equivalence means that the generic drug contains the same compounds as the brand name drug. It also has the same strength, the same route of administration, and the same dosage form.
For a generic to achieve bioequivalence, the generic product must have the same effect as the brand drug. This means that the compounds have the same rate and extent of absorption.
What Makes Them Different
Everything seems exactly the same, so what's the difference? Well, just because the brand and generic have identical drug molecules, and are bioequivalent and pharmaceutically equivalent, that doesn't mean that they're exactly the same in every single way.
The major difference is what the pharmaceutical industry calls excipients.
Excipients are the inactive ingredients in a drug product. Basically, it's anything that's not the active drug molecule.
Why Are Excipients Used In Drugs?
Let's say you have bad heartburn and decide to take 20 milligrams of a popular acid reflux inhibitor. On a scale, the tablet you take will be a lot heavier than 20 milligrams.
20 milligrams is so small, actually taking that amount would be very difficult to do. It would be like taking a few large granules of salt size tablets.
To make taking medicines easier, manufactures will use approved compounds as fillers to beef up the size of the drug tablet. Some of those compounds used are lactose, starch, and hydrocrystaline cellulose.
Other excipients help tablets dissolve in the digestive tract, or improve coloring and flavoring.
It's true, generic and brand name drugs will always have the same active ingredients. However, the big differences depend almost exclusively on the excipients used.
One or the other may have slightly more or fewer types of inactive ingredients. It all depends on their manufacturing processes. Also, manufacturers use different coloring agents to stand out from each other.
This helps to avoid trademark infringement.
What Happens If Generics Aren't Bioequivalent?
So you now know that generic and brand name drugs sometimes vary in what's in their ingredients. However, a company producing a generic drug still needs to prove to FDA that its product is entirely bioequivalent.
Here's an example when this failed to happen.
In the late 1960s, an outbreak of intoxication occurred in Australia. Those affected were patients taking the anticonvulsant drug phenytoin. An alarming 87 percent of patients experienced toxicity drug levels in the blood that put them at risk of side effects.
Some of the side effects included a change in the patience gate, vomiting, and double vision.
What was the culprit behind all of this?
Investigators discovered that the phenytoin capsules' main ingredient for the excipient was lactose. Apparently one manufacture had changed its diluent or bulking agent. They changed it from calcium disulphate dehydrate to lactose.
The lactose used as a bulking agent allowed the phenytoin to dissolve more readily. This lead to higher concentrations in the blood.
What was interesting about this case was that some patients started to experience toxic side effects. Yet, there were others receiving benefits for the first time.
What this shows is that excipients aren't anything to overlook when purchasing generic drugs. It's crucial that brand and generic brands be both pharmaceutically equivalent and bioequivalent.
Today the FDA, the Canadian Food Inspection Agency, and other regulatory bodies are strict about this.
Effectiveness of Generic Drugs
An examination of data from a number of independent studies compared the clinical effectiveness of generic and brand name cardiovascular drugs. The study included 38 randomized controlled trials of 9 different generic versions of these medications.
Surprisingly, bioequivalency was seen in all studies of statins, alpha-blockers, beta-blockers, antiplatelet agents, 1ACE inhibitors, warfarin, and antiarrhythmic agents.
It should be noted that bioequivalency was only seen in 10 of the 11 randomized controlled trials of diuretics. Also, it was only seen in 71% of calcium channel blockers. However, these differences were not major enough to impact clinical outcomes.
Overall the meta-analysis indicated that there was no significant difference between brand and generic drugs.
Why Do Doctors And Pharmacists Sometimes Disagree?
Even though there are ample clinical studies proving that generic drugs are just as effective as name brand drugs, there are many physicians who swear off generics.
A survey of 506 physicians in the US revealed that as many as 23% had negative opinions on the efficacy of generic drugs. Out of that same group of physicians, those over the age of 55 were 3 times more likely to have a poor opinion on generics.
Negative opinions dropped significantly when pharmacists were surveyed about the effectiveness of generic drugs.
Why is it that pharmacists seem to have a more positive outlook when it comes to generic drugs?
Pharmacists spend a lot of time in school learning about the chemical nature of drugs and how excipients work in products. This often time equates to a higher degree of confidence.
On the flip side, physicians may hear first-hand accounts of patients being dissatisfied with generics. This gives them a more personal perspective on the matter.
When Using A Generic Might Not Be As Good
Some pharmaceutical drugs have what is called a "narrow therapeutic index". This means that the drug is only effective within a very small dosage range.
If too little of the drug is absorbed into the body, the drug will have no effect,.
And if too much of the drug is absorbed, then the drug may cause harm to the body.
One example of a drug with a narrow therapeutic index is the blood thinner warfarin. Not all people experience this drug in the same way, and those taking it need their blood checked regularly so that appropriate dose adjustments can be made.
Because of this, physicians and pharmacists are hesitant to use generic versions of this drug.
A review article examined 6 observational studies and 5 randomized control trials comparing outcomes when switching patients from Coumadin to generic warfarin.
The observational studies showed that those switching drugs should be monitored more closely.
However, in the RCTs there were no significant differences reported at all, and in no studies did it show that the branded drug was more effective than the generic version.
Another area where physicians have flagged possible adverse effects from moving patients to generic drugs is psychotropic drugs, such as antidepressants and anti-psychotics.
Saving On Drug Costs Matters
The fact is that most generic drugs are cheaper than their name-brand prototypes. When given a choice to take a medicine or not, it often comes down to whether or not one can afford to.
A study compared adherence to statin therapies in patients that were started on either name brand drugs or generic drugs.
A higher number of patients started on generics were compliant with their medication regiment. Those taking generics had an 8% reduction in hospitalization for acute coronary syndrome or stroke.
Why does this matter?
This matters because it shows that people are more likely to stick to a regiment of taking a medication if it costs less. If the price of the medication is too much to bear, then some people it seems would rather go without.
Generic medications on average cost about 80% to 85% less than the same brand-name drug. According to IMS Health Institute, generic drugs saved the U.S. healthcare system $1.67 trillion from 2007 to 2016.
Yeah, But Why Are Generics So Much Cheaper?
Before a pharmaceutical company can put a new drug on the market, it needs to first patent it so that no one else can try and replicate it. Then it goes through rigorous trials and research development before it has its final product.
All this costs millions of dollars sometimes billions of dollars.
In fact, according to a new study published in JAMA Network, “Changes in List Prices, Net Prices, and Discounts for Branded Drugs in the U.S., 2007-2018," the cost to put a new drug on the market can range from around 314 million dollars to 2.8 billion dollars.
Pharmaceutical companies claim this is why they mark up the prices of drugs so much. (The most expensive drug being Zolgensma, a gene therapy drug for a rare childhood disorder, costs 2.1 million dollars)
When patented drugs lose their exclusivity rights, other companies are able to produce generics at a fraction of the cost.
Are Generics Right For You?
A chemical compound is a chemical compound and as long as bioequivalence is assured, brand and generic drugs should give the same results. Yet, there may be good reason to be cautious when dealing with narrow therapy index type drugs, and psychotropic drugs.
National regulatory bodies require a lot from manufacturers to market generic drugs to consumers. Studies have shown that generics in most cases are just as good.
Key points to take away from this article:
- Generics must be pharmaceutically equivalent as their brand name counterpart
- generics must be bioequivalent as their brand name counterpart
- generics may include different inactive ingredients, such as preservatives, coloring, or fillers
- In most cases, differences between a generic and brand drug do not affect the drug’s performance or effectiveness
- Take caution when using generic drugs with a narrow therapeutic index as well as psychotropics
- Generics cost less than brand name medicines because there are fewer upfront costs to produce them
- Trademark laws prevent generic drugs from looking identical to the brand name drug, so their color and size may be different
- Physicians and doctors don't always share the same opinions on generic drugs
Hopefully, after reading this in-depth article discussing generic vs brand name drugs, you have a better understanding of the differences between a generic drug and a brand name drug.
If you're curious about purchasing medication online from a Canadian online pharmacy, we encourage you to read our article on President Trump's executive order allowing the import of Canadian drugs into the United States.