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Generic vs Brand Name Medications

From a consumer perspective, the main difference noted between generic and brand name options is cost. Read more...

 

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What is a generic medication?


In general, generic medications, and even generic products in general, tend to be alternate versions of a known name brand. This means that generally speaking a brand name company puts research and resources into product development to create something that consumers are seeking. The methods and precise ingredients or components of this original version are proprietary and not necessarily available to replicate. Although the precise quantities and concentrations may not be known, the general list of ingredients tends to be a part of the FDA approval process. This allows other companies to try to replicate the formula or at least come pretty close. Generic drugs are less expensive since they do not have to place a large investment of money towards research and development.


What do generic medications have to prove for FDA approval?


Generic medications have the ability to apply for an abbreviated new drug application (ANDA) by proving that their active ingredient is the same as the brand name option and in the same strength. Although they must provide this information for the active ingredients as the same, the inactive ingredients can vary as long as they do not significantly impact the effectiveness of the medication. The FDA must comply with any patents that the brand name has in place and delay approvals of generics to recognize the cost placed on research and development by brand name products.







What makes generic medications different from brand-name options?



From a consumer perspective, the main difference noted between generic and brand name options is cost. The route of administration, indication, and disclosed strength should not vary by much in most cases.



 


 


Does it always make sense to choose a brand-name medication over a generic one?



Although it is true that the research and development placed on brand name options can provide some people with more reassurance, the reality is that the cost difference is substantial. Generic equivalents can be as much as 80 to 85% less expensive than brand names. For short-term treatment, this may not be unreasonable, but for chronic medication use, the cost adds up. It’s not unreasonable to start with a less expensive medication that is close to the name brand and see if it performs up to par. If your experience shows that it is less effective than anticipated or non-life threatening side effects are noted, then it may be reasonable to discuss with your doctor if the brand name may be worth considering. The inactive ingredients may impact these incidental findings that contribute to your overall experience of the drug.


Are there any circumstances where a brand name is better than the generic option?


There are some drugs worth paying more for. The bottom line is that brands and generic medications are not the same. Generic medications may have the same active ingredients but there is the potential for differences in effectiveness and absorption based on the inactive ingredients. The FDA acknowledges that generic medications are not aware of the precise ‘recipe’ for brand-name medications. Manufacturers of generic drugs have to reverse-engineer these medications. Reverse engineering would be like getting a pair of sneakers and looking at the label that shows its components and trying to make your own version. They only require that the generic medication's concentration of active ingredients not fall below 20% if the name brand or 25% higher. Please note that this does not necessarily mean its 20% less effective or 25% more effective, these values are based on bioequivalence. There are and can be differences in absorption as well.
There are two specific medications that simply have less effectiveness in their generic form in my experience- Neoral (cyclosporine) and Synthroid.






Are there any concerns that physicians have when it comes to generic medications?



Practically speaking, the biggest issue for me as a practitioner comes when a pharmacy switches between two generic versions of the same medication for a patient. For example, one month the patient receives Claravis, and the next they receive Myorisan (both are generics of Accutane, known as isotretinoin). Think about this- if one of those generic’s active ingredients, isotretinoin, is as low as 20% below the brand name’s concentration and the other is 25 % higher- there can be a 45% increase or decrease in bioequivalence immediately. Again, this does not necessarily mean a 45% difference in effectiveness but based on the variation it could mean a potential 5-10% difference in effectiveness from the standard which could translate into a 10 to 20% difference in effectiveness between two generics. This is a problem. We see this in practice routinely where a relatively predictable drug like isotretinoin fails to meet our expectations. For this reason, again practically speaking, it’s often cost-inhibitive to do anything about this. We at least attempt to ask the pharmacy to at the very least try to keep the generic version consistent and avoid switching between generics routinely to avoid these fluctuations.
There are two specific medications that simply have less effectiveness in their generic form in my experience- Neoral (cyclosporine) and Synthroid.

Some people feel strongly that their brand-name drugs work better- is there any truth to this?



Some will swear that the brand name works better for them than the generic- this is not necessarily a placebo effect. It’s simply that the name brand has tested its claims against its product. Generic medication claims are based on an assumption that they will perform the same. If you take the Accutane example again when there was no generic I could precisely say that patients will be on it for 20 weeks. With generics, I have to follow patients and keep them on the medication until they are clinically clear which can vary.
The problem is simply that it’s becoming cost inhibitive to provide care. We are generally not talking about a $4-$5 price difference- it’s often hundreds of dollars to consider.




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