Health Tips

Love some vanilla sandwich cookies? Here you go!

Indeed, the Oreo^® brand of vanilla sandwich cookies receives so much popularity that nobody even calls the product ‘vanilla sandwich cookies’ anymore – they just call it the ‘Oreo^® cookies’. If there is anything amazing about capitalism, is that good (and profitable, ehem) products are rarely manufactured by a single company. Market competition quickly follows suit; many other companies see the opportunity and start manufacturing their own versions of the same product to compete against Oreo^®. Considering Jack ‘n Jill Cream-O. 

Image courtesy of Shopee Malaysia

Now, we won’t be having a debate on which sandwich cookies are the best today; we just wanted to point out that market competition is mostly beneficial, especially for the consumers (that is, us!). When your favorite cookies are manufactured by several companies, you have a bigger variety to choose from, and it is likely that you can get them at a cheaper price.

Good news: market competition also exists in the pharmaceutical world, and that is why you see more than one brand of the same medicine.

Before generic medicines: original medicines

Image courtesy of Stephen Foster

Original medicines (also called brand-names, innovator brands) are the equivalent of Oreo^® in the pharmaceutical world. The story usually goes like this: a pharmaceutical company has been spending billions of dollars developing and testing a new medicine the world has not seen before. Finally, after the medicine showed a good safety profile and promising results in clinical trials, the pharmaceutical company then submitted an application to the United States Food and Drug Administration (FDA). If the FDA is satisfied with the results and documentation, the original medicine is registered and ready to be sold in the market. 

Now, because the pharmaceutical company has invested so much money on developing an entirely new medicine, they would not want anyone to come along and steal their ‘recipe’ to produce a generic version after the medicine is sold in the market. That would hurt the pharmaceutical company’s profit and they could not even begin to recoup the cost of developing and producing the medicine. 

Therefore, new original medicine brands are usually protected by patents (issued by the U.S. Patent and Trademark Office) that prohibit others from selling generic versions of the same medicine for a defined period of time, usually for 20 years. This is known as the patents and exclusivities, which aims to incentivise pharmaceutical companies to invest money in creating innovative medicine for the betterment of humankind. Without this measure, many pharmaceutical companies would refuse to invest billions of dollars to bring new medicine to the market because it is simply a loss-making business.

There comes generic medicines

Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic pharmaceutical company), a generic medicine can be sold in the market.

Generic medicines use the same active ingredients as original medicines and work the same way, so they have the same risks and benefits as the original medicines. They are created to be the same as the original medicine in dosage form (tablets, liquids, powder etc.), safety, strength, route of administration, quality, performance characteristics, and intended use. Essentially, a generic medicine is the Jack ‘n Jill Cream-O to Oreo^®.

Here are some common examples of original-generic medicines you can find in most pharmacies.

Generic medicines are so cheap!

Or to put it in another way: original medicines are expensive! This is because big pharmaceutical companies, usually the original manufacturers, factor in a lot of costs into creating a new medicine: raw ingredients, manufacturing, research and development (R&D) – and also the R&D costs of all the medicines that fail to get to the market. Research pharma companies need to set those costs for failures against the profits from the medicines that work – it’s the only way they can afford to keep looking for new medicines.

Besides, clinical trials to test new drugs for safety and find out how well they work cost millions of dollars, and many drugs look good in the lab or in animals but don’t work in humans – or there are serious side effects. All in all, it takes about 10 years to develop a medicine, and it is an expensive process. 

Of course, another reason that original medicines are so pricey is because original manufacturers know that they have to reduce their prices substantially after generic medicines come into the market. They have a great incentive to charge high prices during their patent and exclusivity period, when there is nobody else in the competition yet. 

On the other hand, generic medicines tend to cost less than their original counterparts because generic medicines makers do not have to repeat animal and clinical (human) studies that were required of the original medicines to demonstrate safety and effectiveness. The drug authority would also approve multiple generic medicines companies to market a single medicine; this creates market competition and lowers the price further. When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name. According to the IMS Health Institute, generic drugs saved the U.S. healthcare system $1.67 trillion from 2007 to 2016. The wonderful thing about a cheaper alternative is better access to treatment, as people no longer have to give up treatment simply because they cannot afford it.

Are generic medicines REALLY as safe and effective as the original?

Just because the approval process for generic medicines are shorter it does not mean that anyone can just go on and make generic medicines. The FDA Generic Drugs Program and our very own National Pharmaceutical Regulatory Agency (NPRA) conduct rigorous review to make sure generic medicines meet a series of requirements. 

Among many strict standards, generic medicine makers must show that their medicine works the same as the original through bioequivalence (BE) studies. This means that chemically the two must be pretty much the same, although makers are allowed 20% variation in the active ingredient from that original formula. Basically just generic medicine makers tried to make their Jack ‘n Jill Cream-O taste as similar as Oreo^®.

However, there is a catch – while companies are required to get the chemical recipe of the generic medicine close to the original, they aren't required to show that the two versions are therapeutically equivalent, meaning that they don't have to do tests to make sure that patients respond to these drugs the same way they do the original version. For instance, the manufacturer of a generic blood pressure medication wouldn't need to prove that its drug also lowers blood pressure. But because the chemical composition of the medication is the same, regulators think it's a pretty safe bet that it will do just that.

So, should you switch?

The short answer in most cases is, yes, you should. Generic medicines are way cheaper than original medicines, and a rigorous review process ensures that they work the same way as the original. Whenever your doctor prescribes a new medicine or changes your prescription, you can ask if there is a generic available and what are the differences between those two. 

Now, generic medicines may look different than their original counterpart. They share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different. You may need to give yourself some time to get accustomed to the new appearance of generic medicine.

In some cases you may choose NOT to switch

• You may not want to change brands to avoid confusion. It’s best not to keep switching brands, especially if you take several different medicines. If you are refilling prescriptions for elderly who are forgetful, it is important to not cause any confusion for their medicine regimen.

• For a few people, there may be risks in changing brands, such as having an allergy or intolerance to an inactive ingredient in a different brand of medicine. Inactive ingredients can include fillers, binders or coatings used in the manufacturing process.

• People with certain conditions may be advised to stick with their original prescribed brand. Your doctor will explain if this is the case.

Ultimately, the choice of switching to generic medicines is your decision, it is crucial to ensure that it is an informed one. 

References

1. U.S. FDA - Generic Drug Facts

2. U.S. FDA - Generic Drugs: Questions & Answers

3. Harvard Health Publishing - Do generic drugs compromise on quality?

4. Harvard Health Publishing - Generic drugs versus brand names: Switching could save money

5. NPS Medicinewise - Medicines and brand names, explained

6. The Conversation - Explainer: how do generic medicines compare with brand leaders?

7. The Guardian - Why do new medicines cost so much, and what can we do about it?

8. Narcolepsy UK - Why are some medicines so much more expensive than others?

Written by

Ms Joyce Toh