Academy of Oncology Nurse & Patient Navigators
Over the years, oncology science has evolved to understand some of the intricacies of the hundreds of types of cancer. Based on this evolving knowledge, diagnostic and treatment strategies have been developed to offer long-time survival for a significant number of oncology patients. As new care processes emerge, healthcare professionals as well as patients must stay abreast of the latest developments. Patients need the knowledge to understand and accept recent technology. Biosimilars are a treatment approach that has been available in the European market for 2 decades and is now becoming popular in the United States. This class of medication treats cancer as well as other chronic conditions like arthritis, kidney disease, diabetes, macular degeneration, multiple sclerosis, and osteoporosis.
What Are Biologic Medications?
Biologics are made from living sources, such as animal cells and microorganisms like bacteria or yeast. Biologics differ from conventional drugs, like aspirin, that come from chemical compounds. Drugs from chemicals can be easily copied or duplicated, whereas biologics from living sources are more complicated to reproduce. An original biologic that is already approved by the FDA is called the reference product.
What Is A Biosimilar Medication?
A biosimilar is a biologic medication product that is almost an identical copy of the reference product, thus the use of “similar.” Biosimilars are made from the same types of sources (animal cells, microorganisms) as the reference product. They are administered the same way, work the same way, have the same dosage and strength, and are like reference products in terms of safety, purity, and potency. They have no clinically meaningful differences from the reference product.
Think of them like loaves of bread that are made from the same recipe. Each mixture of a biologic medication is made from ingredients of living sources. But since living sources have slight differences, each batch is not an exact copy, but each batch makes the same type of bread with slight variations. There are no meaningful differences in each loaf.
Are Biosimilars Generic Drugs?
No. Generic drugs are identical in chemical composition to branded (reference) drugs. Through a chemical process, generic drugs may be exactly replicated. Biosimilars come from living sources (with natural differences), and they are more complicated to produce than drugs made from chemicals.
But both generic and biosimilar products become available when drug companies’ exclusive patents on expensive new drugs expire, and they can be marketed as cheaper versions of costly brand-name medicines that have the same clinical effects as their pricier counterparts.
What Are The Benefits of Biosimilars?
Biosimilars provide patients with lower-cost medicines. They can make treatments more affordable and provide earlier patient access to treatment. Cost savings to the patient can be applied to other treatments or support services if needed. And lower medication costs, which lessen the financial strain for patients, make it easier for them to remain on therapy.
How Safe Are Biosimilars?
Biosimilars are approved by the FDA using a regulatory pathway that focuses heavily on analytical testing that is more sensitive than conventional drug testing and has a greater capability to detect clinically significant differences in structure and function of biological activity. Comparative clinical trials are used, in which patients are randomized to receive either the biosimilar or the reference drug, and their clinical outcomes are compared to ensure there are no significant differences in terms of effectiveness and safety profile. They must be manufactured in accordance with FDA Current Good Manufacturing Practice requirements.
Does a Cheaper Cost Mean Less Effectiveness?
NO! There is no basis to suggest that a cheaper biosimilar drug is of lower quality; the FDA strictly regulates them to ensure they are highly similar to the original biologic in terms of safety and efficacy. Biosimilars are normally priced lower than the original biologic, which can significantly reduce healthcare costs for patients and insurance companies. This is a way to protect patients and offer more affordable alternatives to high-cost medication.
There is a psychological phenomenon called the “nocebo effect” in which negative expectations about a treatment can lead to the development of adverse effects, even if the treatment is beneficial. Patients who experience nocebo effects may not adhere to prescribed treatments and thus interfere with disease control. Patients with cancer can worry that switching to a biosimilar could disrupt their current treatment stability and potentially cause negative effects. To address this experience, patients should focus on the potential benefits of treatment and discuss the specific situation with a healthcare professional to manage any anxieties and make informed decisions.
Why Would a Patient Switch From an Original Biologic to a Biosimilar?
A patient might switch to a biosimilar because of a change in insurance coverage or to save money.
Will I Be Informed If I am Getting a Biosimilar or a Brand-Name Biologic?
Depending on the law in your state, a pharmacist may give you an interchangeable biosimilar in place of the original brand-name biologic medication. For a pharmacist to do this, the biosimilar must be designated as interchangeable by the FDA; pharmacy laws in some states allow for such substitution without consulting the prescriber. Most pharmacists will notify your doctor of the change.
It is normal procedure to discuss the potential benefits and risks of switching to a biosimilar with your doctor, and any concerns about the biosimilar should be addressed with your healthcare provider.
What Side Effects Occur With a Biosimilar?
The side effects for a biosimilar are like the side effects for the original biologic. Because it has minute differences that do not affect the activity of the medication, a patient may feel better on the biosimilar or feel slightly worse. Look for a rash at the injection site and always discuss symptoms such as fatigue, stomach upset, or other effects with your healthcare provider.
Is My Medication Available As a Biosimilar?
Please ask your healthcare providers. You can check trusted sources of information related to your specific condition with disease-specific organizations. Talk with your insurance provider or refer to the insurance policy’s formulary of covered medications to see if an insurance plan covers a biologic and/or its biosimilar alternatives. Also visit the FDA site for a list of FDA-approved biosimilar products.
Biosimilars are part of the evolution of cancer care to enrich treatment and create broader healthcare access and lower costs for patients. As the momentum for biosimilars in the United States continues to grow, patients will need to be on the forefront of knowledge to make informed healthcare decisions.
