Oncology nurses need to be aware of new treatment options, such as biosimilars, to educate and respond to patients’ questions. Puja Patel, PharmD, BCOP, clinical oncology pharmacist from Northwestern Medicine Delnor Cancer Center, presented a session at the 2022 ONS Bridge Conference that provided an excellent overview of biosimilar drugs and the key role of oncology nurses in helping patients and their caregivers understand this treatment option.
What Is a Biosimilar?
“Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an FDA-approved reference product,” states Dr. Patel. “A reference product is the ‘originator’ drug to which the proposed biosimilar biologic product is compared.” For example, bevacizumab is a reference product with 3 biosimilar drugs now available (bevacizumab-awwb, bevacizumab-bvzr, and bevacizumab-maly). Regarding a biosimilar having no clinically meaningful differences, “this means a patient will have the same safety and effectiveness from the biosimilar over the same course of treatment as you would the reference product,” explained Dr. Patel.
Why Did Biosimilars Come to Market?
Biosimilars have come to market as patents for the first generation of reference biologics have expired. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was developed in association with the Affordable Care Act (ACA.) Under President Barack Obama, the BPCIA created an abbreviated regulatory pathway for the FDA approval of biosimilars.
Some of the benefits of biosimilars and this abbreviated pathway are:
- Increase in drug access
- Competition (thus decreasing cost)
- Shorter development to approval time
- Reduction of health care burden
In addition, biosimilars may offer additional treatment options to patients, leading to better health outcomes.
What Are the Differences Between Generic and Biosimilar Drugs?
Although it is a helpful analogy to think of biosimilar drugs as generic drugs, Dr. Patel reminded oncology nurses of several key differences: “Generics are chemically synthesized and can be copied more easily. Generic drugs are the same within each drug lot and between lots. Biosimilars, however, are natural, living systems. Because no 2 living entities can be the exact same, there are some slight differences between biologics although they are still similar.”
How To Know These Differences Are NOT Clinically Meaningful?
Reference products and biosimilars are approved through different regulatory pathways to decrease biosimilar cost and development time. However, biosimilars remain highly similar to the reference product, and there are no clinically meaningful differences between the biosimilar and the reference product in terms of quality, safety, and efficacy. Still, biosimilars do not need to repeat the clinical trials the reference product underwent to establish safety and effectiveness. The “totality of evidence” (the results from the reference product’s approval process and the biosimilar approval process) supports biosimilars as a highly safe and effective option for patients.
When the health care team, especially the oncology nurse, has a strong understanding of biosimilars, patients will have increased confidence in their treatment options, and increased use of biosimilars as a safe and cost-effective treatment in oncology care can occur. As the most trusted group of health care professionals and those who spend the most time with patients, Dr. Patel feels oncology nurses are firmly positioned to increase the adoption of biosimilar drugs.
FDA: Biological Product Definitions
FDA: Biosimilar Patient Materials
FDA: The Biosimilar Development Process
Biosimilars in Oncology: Key Role of Nurses in Patient Education