Frequently Asked Questions About Biologic and Biosimilar Drugs


Q. What is a biologic? 

Answer: Biologics are a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell. Like all drugs, biologics are regulated by the Food and Drug Administration (FDA). 

Biologics are different from “small molecule” drugs (think aspirin) in that they are generally larger, more complex molecules. Biologics are usually administered via injection or infusion. Most biologics in cancer care are given under the close supervision of a medical professional.  

Q. What is a biosimilar?

Answer: A biosimilar is a biologic product developed to be highly similar to a previously FDA approved biologic, known as the reference product. A biosimilar must have no clinical differences to the reference product. This means that a patient using a biosimilar can expect the same physical responses to the biosimilar as they would to the reference product.

A biosimilar is considered highly similar to the reference product and it is as safe, pure, and potent as the reference product for the conditions, also known as the indications, for which it is approved to be used. In order to be deemed a biosimilar, the product will have the same mechanism of action (how it works in the body), route of administration (e.g., injection or infusion), dosage form, and strength as its reference product. 

Q. Why does the biosimilar pathway exist?

Answer: Biologics have become an increasingly important part of health care. With the increasing attention to the costs of drugs, it became apparent that there was a need to create competition and choice that would lead to better access in the biologic marketplace. The pathway for generic drugs created in 1984 did not provide a pathway for the approval of biosimilars. In 2010, FDA was given the authority to approve versions of biologic products that would provide competition and likely lower cost alternatives to “brand name” biologics. 

The biosimilar pathway depends on a head-to-head comparison of the proposed biosimilar to a reference product. By focusing on a comparative analysis, biosimilars can be approved without the need to complete the same number of costly clinical trials as the reference product. However, because of the FDA’s strict standards, patients can nonetheless be assured that the biosimilar product is as safe and effective as the reference product.   

Q. Will a biosimilar work the same as the original product?

Answer: Yes, you can expect that there will be no clinically meaningful difference between an original biologic product and a biosimilar. All FDA-approved products undergo rigorous evaluations to ensure safety and efficacy, and are made in inspected facilities to the same high-quality manufacturing standards.

Additionally, biosimilars have a long record of clinical effectiveness and safety around the world. Over 30 biosimilars have been approved and used in Europe since 2006. The evidence collected in that time shows that biosimilars are as safe and effective as their reference products.    

Q. Will biosimilars save me as much money as generic drugs? 

Answer: At the present time, biosimilars are not expected to offer as large cost savings as generic drugs. Even in Europe, where the biosimilar market is more established, prices have not yet dropped as steeply as they have for generic drugs. While generics can experience discounts of up to 80%, biosimilars tend to have cost discounts averaging about 20 to 30 percent (although in some cases they have been 70%). Even with these percentages, the overall savings can be significant.

As there are currently a limited number of biosimilars on the market in America, it remains to be seen how much cheaper they will be and how they will affect the marketplace. This discrepancy may be in part because the development costs and timelines for biosimilars more closely mirror that of standard drugs, rather than that of generic drugs. However, with time, experience, and additional competition, biosimilars should offer patients additional savings.  

Q. How do I know if I am getting a biosimilar or a brand-name biologic?

Answer: Unless an interchangeable biologic product is available (see below), you will receive the biologic product that your healthcare provider prescribes for you. Your healthcare provider may have various reasons for selecting a branded biologic or biosimilar, including experience with the product, your health plan’s formulary (permitted drugs), patient preference, cost consciousness, or some combination of these factors. You should ask your health care provider if you have questions.    

In the instance when a biologic may be dispensed by a pharmacy directly to a patient, only an interchangeable biologic product can be substituted by a pharmacist without the consultation of a prescriber. This practice is known as substitution (a practice commonly used for generic drugs).  At this time, there are no approved interchangeable biosimilars.

Q. What is the difference between a “biosimilar” and an “interchangeable biosimilar”

Answer: Interchangeable biosimilars are biosimilars that have met additional requirements. These requirements include not only showing that the product is expected to produce the same clinical result as the reference product in any given patient, but also that switching back and forth between the reference product and the biosimilar causes the patient no additional risks in terms of safety or effectiveness as using only the reference product. 

Currently there are no interchangeable biosimilars available in the U.S.

From a patient’s perspective, the key difference between a biosimilar and an interchangeable biologic is that an interchangeable biologic can be substituted for the reference product by a pharmacist (subject to state law#) without the involvement of the prescriber. However, the FDA’s high standards for all biologics, including interchangeable biologics, means that you can be assured of their safety and efficacy, including in those instances where you may switch back and forth between the reference product and the interchangeable product. 

#- Most, but not all, states have laws that allow substitution of interchangeable biosimilars, but in these states a physician can prevent such substitutions.  The specific laws and rules vary from state to state, but typically the physician would mark “Dispense as Written,” or a similar statement, on the prescription to prevent such substitutions in states where substitution would otherwise be allowed, or would mark “Substitution allowed,” or a similar statement, on the prescription in states where no substitution is normally allowed.  

Q. How are biologics (and biosimilars) used in cancer treatment? 

Answer: Biologic therapies play an important role in cancer treatment. Many biologics work by using a patient’s own immune system, directly or indirectly, to fight cancer. Some biologics target cancer cells for destruction, while others work to reduce the side effects from chemotherapy or radiation.

Q. Can a biosimilar be used for all of the same uses as the innovator product?

Answer:  A biosimilar can be approved for one, some, or all of the same indications as the reference product. However, a biosimilar may have fewer approved uses or “indications” than the reference product due to patent rights or other unexpired “exclusivity” rights for the reference product. The biosimilar will work in the same manner of the reference product for all indications. 

Your doctor should review the prescribing information and approved indications to determine the most appropriate product for you.

Q. What can patients expect as biosimilars become more common?

Answer: Patients can expect a growing number of choices in their cancer treatment. As additional biosimilars come to the marketplace, patients can expect to see changes in the biologic products offered on different health plans to include both brand-name biologics and biosimilars.  The introduction of biosimilars is also expected to reduce costs of these drugs. 

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