This post aims to raise awareness of medications which are “similar” copies of an original drug, but usually sold at a lower cost. Are they actually the same? Are you getting a “cheaper” product that is not of the same quality?
What are generic medications?
Let me start with an example. If you visit your local pharmacy because you are looking for a pain killer for a bad headache, the pharmacist may recommend you try ibuprofen, which is a non-steroidal anti-inflammatory drug. However, depending on the brand of ibuprofen you buy, the price may be different. All brands would however contain the same ibuprofen, usually at exactly the same dose.
Generic medications are thought to be equivalent medications to the original brand name drug, and contain a nearly similar composition in each tablet (same active drug, same dosage, similar excipients – i.e. other components which make up the tablet).
What are biosimilar medications?
Biosimilars are not exactly the same as generics. If with generics you are getting the exact same chemical under a different brand name, biosimilars are “almost” the same. The reason biosimilars are not exactly the same is because they are very complex drugs, with large and complex chemical molecules. For this reason, the production process cannot be replicated exactly by a different manufacturer.
While this may seem like you are getting a completely different drug, this is not the case. Approved biosimilar medications are actually nearly 100% comparable in their biological effects, despite having some slight differences to the original brand name drug. Therefore, they also help control very serious conditions in the same way, but a lower cost. Overall, this is an advantage, because more patients can be treated and have the opportunity to control some very serious conditions.
Why do we need generic and biosimilar medications?
You may be surprised to find that a lot of the medication used around the world is actually generic, with a slow and steady uptake of biosimilar medication. These products have actually played a huge role in improving access to effective treatments especially in low income communities and countries. This is especially true when considering very costly treatments, such as the ones used for cancer therapy or rheumatological disease. Many countries around the world would not be able to afford using original brand name medications due to their prohibitive costs.
Saving costs in this way, by using equivalent or similar medications while preserving nearly the same efficacy, leaves more money available in the health system. These funds can then be used to treat other conditions, to provide preventative medicine programs, to employ more staff, offer better hospital facilities etc. If all the money would be spent on buying medication, we wouldn’t be able to provide good quality medical services. Treating disease involves more than just selecting the right drug.
How are these medications approved?
With generic medication, because they contain a fairly simple drug compound, we would only need to prove that the generic tablet contains the same “ingredients”, is absorbed in the body in the same way as the original medication, and that the quality control mechanisms at the production site are sufficient to ensure that each tablet is the same every time.
The pharmaceutical company seeking to get approval to sell a generic tablet would need to demonstrate the above using specific scientific studies (bioequivalence studies), and the production site will have to demonstrate having certain standards of practice, may be inspected by regulatory authorities or demonstrate quality in other ways.
In most countries, generic medicines can only be produced after a few years after the original drug has been used. This also ensures that the active drug is safe to use at scale. Generics then replicate this already established drug, at a lower cost.
Biosimilars are more complex therapies, generally used for the treatment of cancer, rheumatological or autoimmune disease. Biosimilars medications are generally replicas of new treatments, and they contain complex molecules that modulate the body’s immune system or other processes. For this reason, their mechanism of action is not as easily predictable as with simple chemical drugs.
If a pharmaceutical company wants to produce a biosimilar, they not only need to show that the drug is produced to a high standard and that the drug molecule is nearly the same. They often also need to run studies with human participants, to ensure that the biosimilar engages the same targets in the body as the original therapy. The effects of the biosimilar cannot be much “worse”, or much “better” than the original, and the side effect profile needs to also be the same.
Basically, a biosimilar is a nearly identical therapy that needs to also act in the same way. Obtaining biosimilars of equivalent potency is extremely difficult. Biosimilars are generally produced by very large, established pharmaceutical companies, as the production process is extremely complex. Also, it requires a fairly large investment to run the appropriate studies required to demonstrate that the therapy is nearly identical to the original.
Biosimilars require much more complex studies for approval compared to generics.
Why are generics and biosimilars cheaper?
Producing pharmaceuticals is no easy task. Whatever your views on the pharma industry may be, it’s hard to ignore the huge investment required to design and test an effective drug, to produce it the exact same way every time and to scale up production and distribution to a country-wide or global level.
From the initial concept to having a drug that you can purchase in a pharmacy can sometimes take up to 10 years or more. During this time, the company invests huge amounts of money in laboratory and clinical studies, staff, putting together all the evidence to convince regulatory agencies that the drug has more benefits than risks and setting up the infrastructure to produce it at scale. This huge undertaking comes at a very significant cost and this will be reflected in the final price of the drug. The more complex the drug, the larger the cost to develop it, and the bigger the pressure from investors to sell the drug at a high price to recover the investment and make a profit. For all its potential faults, the pharmaceutical industry drives progress in drug development because of this competitive nature.
In very simple terms, manufacturers of generic and biosimilar medications can skip many of these development steps. They will licence and produce a drug that is already established and has been used for many years in clinical practice. As the efficacy of this medication has already been confirmed by its widespread use, repeating very complex clinical trials is not necessary. The generic or biosimilar company doesn’t need to reinvent the wheel, but just to prove that their product is comparable to the original and set up the production and distribution. Therefore, their initial investment is usually much lower. For the patient, this will be reflected in a lower cost for the generic or biosimilar medication.
Are generic and biosimilar drugs “pirated” drugs?
Absolutely not. No pharmaceutical company can operate in a regulatory vacuum. All medications distributed in a health system or through pharmacies have to pass through a very strict approval process. Government agencies are well aware of which drug is sold by which company. They also control which medications are allowed on the market. Unless the medication is deemed safe to use as appropriate and of a good quality, it cannot be sold.
Therefore, generic and biosimilar medications are not “bootleg” pharmaceuticals at all. They still need to pass very strict regulations. In fact, the pharmaceutical industry as a whole is probably one of the most heavily regulated, to ensure the safety of the public.
Generic and biosimilar companies who are successful also tend to be quite large. It is not uncommon for large pharma companies to produce both original and generic medications. They may have their own new drug development pipeline, but at the same time invest in producing established medications.
Summary and takeaways
From a scientific perspective, taking a nearly similar or equivalent drug of a different brand would not lead to a significant difference in health outcomes. The cost savings would then help to ensure that more patients can afford taking the medication they need and health systems could use these savings for other services. Generic and biosimilar therapies are approved using strict regulations to ensure the safety of the public.