FDA Approves 50th Biosimilar Agent—Which Is Also the 25th Approval in Oncology
Medicine marked a major milestone in April 2024, the U.S. Food and Drug Administration (FDA) said (https://www.fda.gov/news-events/fda-voices/milestone-facilitating-development-safe-and-effective-biosimilars), when the agency announced it had approved its 50th biosimilar medication. Trastuzumab-strf, a biosimilar to the antineoplastic trastuzumab, had the honor (https://www.fda.gov/drugs/biosimilars/biosimilar-product-information) of being the agency's 50th approval.
A biosimilar is highly similar (https://www.ons.org/sites/default/files/2024-02/Huddle%20Card-%20Biosimilars.pdf), but not identical, to an already FDA-approved biologic, which serves as its reference product. Unlike generic drugs, which are exact copies of traditional chemical drugs, biosimilars are made from living organisms and have small, naturally occurring variations that have no clinically meaningful difference and do not affect the safety, efficacy, purity, or potency of the product. In the United States, biosimilars are approved (https://www.fda.gov/news-events/fda-voices/milestone-facilitating-development-safe-and-effective-biosimilars) for 15 different reference biologics that treat illnesses such as cancer as well as rheumatoid arthritis, inflammatory bowel disease, psoriasis, diabetes, macular degeneration, osteoporosis, and more.
Biosimilars are one way to address access to and affordability of cancer care. “Biologics are some of the most expensive treatments in the United States, and approving biosimilars can enhance competition, drive down costs to healthcare systems, and increase patient access to biologic therapies,” FDA leaders said in an April 2024 blog post (https://www.fda.gov/news-events/fda-voices/milestone-facilitating-development-safe-and-effective-biosimilars).
Citing data from a 2023 study (https://accessiblemeds.org/sites/default/files/2023-09/AAM-2023-Generic-Biosimilar-Medicines-Savings-Report-web.pdf) conducted by the Association for Accessible Medicines, the FDA authors wrote, “Collectively, patients have used biosimilars for almost 700 million days of therapy, 344 million days of which patients received care they otherwise may not have received. Biosimilars have saved the healthcare system $23.6 billion since the first product was approved in 2015.”
In 2018, FDA launched its Biosimilars Action Plan (https://www.fda.gov/drugs/biosimilars/biosimilars-action-plan), which outlined strategies for:
- Enhancing the efficiency of the biosimilar product development and approval process.
- Maximizing scientific and regulatory clarity for the biosimilar product development community.
- Developing effective communications to improve understanding of biosimilars.
- Supporting market competition by reducing attempts to unfairly delay competition.
The agency used the milestone to announce a summary report of its accomplishments (https://www.fda.gov/media/178015/download?attachment=) toward those goals.
The first biosimilar for cancer treatment, bevacizumab-awwb, was approved (https://voice.ons.org/news-and-views/fda-approves-first-biosimilar-for-cancer-treatment) in 2017. As of June 2024, 25 biosimilars are used (https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs/list.html) for oncology indications. After working with them in practice for nearly seven years, oncology nurses may be familiar and comfortable with biosimilar medications in cancer care, but for many new patients, cancer treatment may be their first encounter with a biosimilar agent. Find the information you need to confidently educate your patients about biosimilar medications in the resources listed in the sidebar.