Generic Drugs vs. Branded Drugs vs. Bioequivalence vs. Biosimilars vs. Patented

By Christine RamirezOct 10, 20213010

Several Americans are unhappy about the skyrocketing healthcare products and treatments. They are expensive, and the majority of Americans cannot afford them. In 2016, the US government used $450 billion on prescription-based drugs, and they estimated to spend $610 billion till 2021.

However, around 90% of medicines prescribed are generic drugs, and 74% are branded drugs. When we compare generic drugs vs branded drugs, generic drugs save millions of Americans every year. It is a known fact that generic drugs save approximately $253 billion of consumer’s money. Yes, in the pharmaceutical business generic drugs plays an important role as they are much affordable and accessible than branded drugs.

Facts: generic drugs vs branded drugs

• Both, generic drugs and branded drugs are approved by the FDA. It confirms that they are safe to be sold in the US pharmaceutical market.
• Not all branded drugs have their generic versions.
• Brand medication is an innovation that gets first launched in the market. It is patented to protect its rights and active formula.
• When you compare generic drugs vs patented drugs, these drugs meet the same quality, potency, and purity standards.
• Generics demand to have the equivalent potency, dosage, route of administration, and active components as the initial branded drug.
• The generic drugs vs branded drugs are different in terms of appearance such as size, shape, color, etc.
• Generic drugs are affordable than the branded versions.

What are generic drugs?

Generic medications are chemically the same replicas of branded or patented drugs. The importance and advantage of generic drugs are they are cheaper than brands. Therefore, they help save a lot of treatment capital. In fact, generic drugs are 85% cheaper than the branded medications.

Generic drugs gain an FDA after detailed reviews from the FDA and after a specific period when the brand drug has been in the market exclusively for several years. It happens when the branded FDA-approved drugs are protected with intellectual property rights. The patents prohibit other pharmaceutical companies to make their exact copies.  

Generic drugs are cost-effective than the branded medicines. It is because generic drug manufacturers do not need to repeat the clinical research studies on animals and humans. However, branded needs clinical study results, to demonstrate the safety and effectiveness of their drug. This whole process helps the new drug manufacturers to gain a patent. 

The drastic reduction in the research costs means generic drugs offer the same therapeutic benefits as their branded counterparts. This is the reason why patients chose generic drugs over branded drugs. Generic drugs are typically sold at discounted rates than the branded drugs. The IMS Health Institute states generic drugs saved the U.S. healthcare system around $2.2 trillion from 2009 to 2019.

Let’s know about: generic drugs vs patented drugs 

When we talk or compare generic drugs vs patented drugs, it is nothing different from generic vs branded drugs. The FDA provides patents to the branded drug that gets launched in the market. A patent is defined as intellectual property rights to the innovator or its company. It protects the new innovative drug and inhibits the production of the same drugs until the patent is valid. When the patent is valid, generic drugs are not made to compete with the branded drug

However, when the patent gets expired, the active formula is not exclusive. Therefore, generic drugs can get marketed easily. Though, the generic drugs also need FDA testing and approval to arrive in the market.

The contrasting feature in generic drugs vs patented drugs is their cost and their packaging and appearance. Also, generic drugs need to meet the same quality, safety, and effectiveness standards as brands. Many active pharmaceutical ingredients are not produced in the US but instead; in countries like China, India, etc.

A drug can be manufactured as a generic medicine when:

• The patent of the branded drug gets expired.
• The generic drug manufacturing company certifies that the patent given to a particular company is either unenforceable, are invalid, or would not be encroach on 
• There is no patent available on that drug.
• In other countries where that drug lacks patent

The appearance of generic drugs vs patented drugs

The trademark law in the United States does not permit the generic drug to have the same trademarks of a branded medicine. Generic medicines and brand-name medicines do share the same clinical significance. However, inactive components such as colors and flavorings do not impact the mechanism, safety, or effectiveness of the manufactured generic drug.

What should you know about generic drugs and bioequivalence? What are they?

All the pharmaceutical terms that we are discussing as far now are related to each other. Similarly, bioequivalent drugs are those that are similar in terms of active chemical composition and action mechanism. 

While manufacturing a generic drug, the company must conduct research studies to conclude whether its generic drug is bioequivalent to the original drug. Therefore, generic drugs and bioequivalence are the terms that are very common when a generic counterpart is produced for launching in the market. The generic counterpart should work to release the active component in the bloodstream essentially at the same time and with the same volume as the branded medicine.

Although a generic drug contains a pre-approved active pharmaceutical ingredient, which has already been tested for efficacy and safety, bioequivalent drugs are launched after bioequivalence fda tests. It is conducted to confirm whether the generic counterpart is the same as the branded drug when it enters the bloodstream. It is just an extra study to avoid health hazards because of replica medications. The generic drugs and bioequivalence study is extremely important to establish the safety of that product. This study tests the manufactured product on a relatively small number of participants.

You might think that only oral drugs are only tested for bioequivalence, but other forms of medicines such as injections, patches, inhalers, and other generic drugs are also tested. The bioequivalence fda standards are available for various types and forms of medications.  

The producers of the branded or patented drugs should also prove the bioequivalence of the newly produced branded drug. This way, the consumer gets safe bioequivalent drugs. Any new forms of the brand drug with any modifications in the dosages or strength of an existing drug should undergo a bioequivalence fda test.

From time to time, the existing branded form is tested and altered for commercial purposes. For instance, the branded tablets should be made robust; in terms of flavoring, coloring, or inactive ingredients to enhance the marketing of new modified branded drugs. 

What is a biosimilar product?

A biosimilar is a type of biological product with “no clinically meaningful differences” from a pre-approved FDA product.

What are Biologics?

Biological products are FDA-approved, used for diagnosis, prevention, treatment, and cure diseases or medical conditions. There are diverse ranges of biological products, which are generally large, complex molecules. These products are produced by a living organism through biotechnology, using a microorganism, plant cell, or animal cell. Basically, they are produced through a living system; a complex protein is made. 

The United States has approved many biological products, including therapeutic proteins such as filgrastim, monoclonal antibodies such as adalimumab, and vaccines such as tetanus.

Some common biologics products are:

• Vaccines (cervical cancer vaccine)
• Blood and blood products (insulin hormone)
• Gene therapies 
• Tissues for transplant (such as ligaments)
• Recombinant proteins (Coagulation factor VII used for Haemophilia A treatment) 
• Stem cell therapies for treating certain types of cancers
• Monoclonal antibodies 

What should you know about biosimilar drugs vs biologics?

Now, as you know what biologics are, you might have understood that biologics are expensive. But the new law was passed, introducing biosimilar products for more treatment options and accessibility at the lowest price. Once all the patents and official rights are invalid on a biologic, another manufacturer can produce a “highly similar” product called a biosimilar.

So when we talk about biosimilar drugs vs biologics, you can relate it with generic drug vs branded drug theory for comprehending. FDA needs a biosimilar drug to be highly similar to the existing FDA-approved biologics. Therefore the US FDA approves a biosimilar drug when: 

• It works in the same manner, has the same strength and dosage. Its mode of administration should be the same as the original biologics.
• The biosimilar drug does not have clinically meaningful differences in terms of safety and efficacy compared to the branded biologics.
• It has the same high standards of manufacturing as the original product.

Biosimilar drugs development saves a lot of time, capital, and resources of a manufacturer by avoiding needless duplication of clinical studies.

What are the differences: biosimilar drugs vs generic?

After understanding what is biosimilar drugs vs generic in detail. You must know generic drugs vs biosimilars. Biosimilar products are not identical replicas of biologics. Instead, they are highly similar to a pre-existing reference biologic or active ingredient. It is the major difference when we talk about biosimilar drugs vs generic.

When we discuss the differences between generic drugs vs biosimilars, we must know that generic medicines contain small ingredients. The small ingredients are very easy to replicate and reproduce. The active pharmaceutical ingredient in a generic drug is the same as the active ingredient in a branded drug.

However, biosimilars contain minor variability and might have slight differences in inactive ingredients like the original biologic product. But they are highly similar to the pre-existing product. 

The similarity between generic drugs and biosimilar drugs is they offer diverse treatment options being cost-effective. These are the most suitable options for patients or consumers. 

Let’s know the difference between bioequivalence vs biosimilar

After knowing about bioequivalence and biosimilar terms, now it’s time to know whether biosimilar drugs can be tested for bioequivalence? Let’s find out about bioequivalence vs biosimilar.

In the coming years, patents of a wide range of biopharmaceutical drugs or biologics are going to expire soon. Therefore, in such a condition, it is opening an opportunity for the generic competition of biologics. It is a known fact that these biological drugs have become an essential and integral part of pharmacotherapy in treating different cancers or genetic disorders. 

Besides, biologics are allowing generic manufacturers to produce follow-on biologics or biosimilars. The new term follow-on biologics is widely used in the USA and Europe for biosimilars. Several biosimilar drugs have already received approval in many countries of Europe.

So, why biosimilar drugs do not require a bioequivalence test? 

The marketing and launching of usual generic medications is an easy job, which costs around $ 2 million only. But keeping in mind the nature of biologics, conducting a bioequivalence study for it is a challenge. Numerous clinical trials and clinical studies need to prove the equivalency and safety of biologics that would cost nearly $ 40 million. 

Still, this cost is lower than launching a new drug, which surpasses $ 1billion. The regulatory agencies have realized that the bioequivalence of biosimilars differs from generic medications. Manufacturers that produce biosimilars must accomplish the quality, efficacy, and safety requirements. 

However, understanding the capital expense for bioequivalence of biosimilars is compared with a reference product. A biosimilar product should be highly similar to the reference product. 

Research studies are still ongoing regarding the bioequivalence of biosimilars. Some European regulators have created guidelines for bioequivalent biosimilar drugs or products. 

How does FDA approve biosimilar products?

As biosimilar products are highly similar to the reference products, they are safe for medical purposes. They can gain FDA approval. The Biologics Price Competition and Innovation Act (BPCIA) offer an easy alternative for receiving FDA approval for biosimilar products. It contains a difficult evaluation to ensure patients' efficacy, safety, and quality of biosimilar products. FDA relies on existing data regarding the safety and effectiveness of a pre-approved reference product for supporting the safety of a biosimilar.

For controlling the nonclinical and clinical data of the reference product, the biosimilar manufacturer must prove its biosimilar product is highly similar. And it has no clinically meaningful differences from the reference product.

This process leads to a faster approval from the Food and Drug Administration to the biosimilar, and immediately it is made available to the patients at the lowest price.