Generics and Biosimilars | 7 Important Questions, Answered

In the world of prescription medicines, there are several medication types. These include brand-name medications, generic medications, biologics, and the newest of them all, biosimilars.  This can be a confusing landscape, but this article will walk you through each drug type, how it is developed, and its main differentiating factors from other drugs.

Brand-name Medications

Brand-name medications are generally small molecules manufactured through chemical processing – meaning, specific chemicals are carefully mixed in a “recipe” that is effective and safe for a specific condition or symptom. These brand-name medications are developed by a pharmaceutical company and approved by the U.S. Food and Drug Administration (FDA) to treat specific symptoms or diagnoses.

1.) How Are Brand-name Medications Developed and Approved?

This is a long and expensive process, sometimes spanning 10 years or longer, with a cost of up to several billion dollars. Specific steps must be followed in the drug development process:

• New brand-name medications are first tested in the laboratory and then in different species of animals.
• After FDA review and approval, the newly developed medications can be tested in people. First, small numbers of people are exposed to the new medication. Then, after a review of data and approval by the FDA, larger numbers of people are exposed to the new medication under the very tightly controlled process of clinical trials.
• Once the drug has demonstrated in large and carefully controlled clinical trials that it is safe and works on the condition or symptom, the pharmaceutical company applies to the FDA for review and approval. FDA approval means that the drug company can manufacture and market the medication.
• When a new medication is discovered, the drug company applies for patent protection. Patent protection for medications lasts for 20 years, meaning no other company can make and market that particular medication with the patent-protected formulation until the patent period has expired. After that, a generic medication can be made, sent to the FDA for approval, and marketed.  Patent protection has expired for several oral and one injectable MS disease modifying treatment (DMT) and generic formulations are now available.

Generic Medications

The FDA states a “generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart”. (FDA-generic drugs, accessed 11/28/2022)

2.) How Are Generic Medications Developed and Approved?

• A company can make a generic medication using the same formulation as the brand-name medication once the patent protections for the brand-name medication have expired.
• The FDA has a rigorous process that must be followed for generic approval. The generic manufacturer must prove that the generic has the same formulation and behaves the same way in the body as the branded drug. If the FDA approves a generic formulation, it can then be manufactured and marketed.
• Generic medications cost less than the brand name because early laboratory and clinical trials are not needed for generic approvals.

Numerous medications for MS symptoms are available as generic medications. Generic forms of certain oral disease-modifying therapies are also available, and more will be available in the coming years.

Biologic Medications

Unlike other medications manufactured through a chemical process, biologics are defined as medications (sometimes called products) that contain one or more active substances made from human or animal materials through very complex processes. The first iteration of a particular biologic medication approved by the FDA is referred to as the biologic reference product.

3.) How Are Biologics Developed and Approved?

• Biologics must go through pre-clinical (laboratory and animal) research and clinical trials to ensure they work as intended and are safe.
• Before each step in the development process, the FDA must provide review and approval.
• Following the completion of clinical trials determining the product is safe and works as intended, an application is made to the FDA for review and approval. The FDA carefully reviews all the data and documentation and renders a decision.
• Like other medications, biologics have patent protection, and a biosimilar medication cannot be manufactured or marketed until the patent protections have expired.

Biosimilar Disease Modifying Therapies for Multiple Sclerosis

Drugs that are modeled after the biological reference product are called a biosimilars. Like the original biologic product (also called a reference product), a biosimilar is very complex and made from human or animal cells. According to the FDA, “a biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product”.

4.) How are Biosimilar Disease Modifying Therapies Developed and Approved?

A manufacturer must demonstrate that its proposed biosimilar product is similar in structure and function and has no clinically meaningful differences from the reference product in terms of safety, purity, and potency (safety and effectiveness). (FDA-Biosimilars, accessed 8/16/23) In the US, a biosimilar of the reference product, Tysabri® (natalizumab) was approved by the FDA in August 2023. Tyruko® is the brand name of the biosimilar.

The FDA makes sure biosimilars are as safe and effective as the original product

• Approving biosimilars after a careful review of data, studies, and tests.
• Monitoring safety and effectiveness after approval.
• Checking for medication quality during production.
• Reviewing patient safety reports made to FDA.

Other Important Considerations

5.) What is the difference between a Generic Medication and a Biosimilar Product?

As mentioned earlier, a generic is a medication that is able to demonstrate bioequivalence to its name-brand drug. A biosimilar must prove that there are no meaningful differences between the biosimilar and the reference product. The reason why a biosimilar is “similar” but not an exact replica is because ALL biologics exhibit variation. Reference biologics have variations just as biosimilars have variations. However, the FDA is very strict about how highly similar a biosimilar must be to the original biologic; the variation is tightly controlled and is constantly analyzed in the manufacturing process. One might ask, “How different can a biosimilar be from its reference product?” The answer is that a biosimilar is as different from the reference product as the reference product is from itself.

According to the FDA, approved biosimilars have no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.

6.) Are generics and biosimilars as effective as brand-name medications?

Generics and biosimilars must go through rigorous processes to demonstrate their effectiveness as compared to the brand name or biologic products. The testing and approval process is different for a generic vs. a biosimilar, but the bottom line is that the generics or biosimilar products MUST have the same structure, be metabolized in the same way, affect the condition or disease in the same way, and have similar side effects and risks to the original branded products.

7.) Why are generics and biosimilars significantly cheaper than brand-name medications?

Although generics and biosimilars still go through very rigorous approval processes because they reference the formulation and structure of the original medications, they save time, money, and resources when developing their product. Additionally, when generics and biosimilars of brand-name drugs come to market, it increases the competition in the disease-modifying therapy space which also helps decrease the cost of treatments.

There are many generics and biosimilars that have been FDA-approved for various conditions and diseases.  The existence of generics and biosimilars has increased affordable access to cutting-edge medications and has reduced overall healthcare costs by trillions of dollars each year.

The actual cost to you may vary based on your prescription coverage. It is always a good idea to check with your prescription provider to understand your out-of-pocket cost before you fill your prescription or start a treatment.