Biosimilars are gaining attention in oncology, offering an alternative to biologic therapies. These drugs are designed to provide similar therapeutic effects as their biologic counterparts but come at a reduced cost. For cancer patients, biosimilars present an opportunity to access life-saving treatments more affordably, but many are still unaware of what they are and how they work.
What Are Biologics?
Biologics are advanced medications derived from living organisms such as animal cells, bacteria, or yeast. Unlike traditional chemical drugs, biologics are complex protein molecules created inside living cells through intricate processes like controlled gene expression and recombinant DNA technologies.1 Because they are made from living cells, no two batches of a biologic drug are exactly the same. Common biologic drugs include insulin, growth hormones, and antibodies, which are used to treat conditions like diabetes, psoriasis, rheumatoid arthritis, and some forms of cancer.
What Are Biosimilar Drugs?
When the patent of a biologic drug (known as the reference product) expires, manufacturers can produce highly similar versions called biosimilars. Biosimilars are designed to match the reference biologic drug as closely as possible, though their complex production process means they cannot be exact replicas. Nonetheless, biosimilars are safe, effective, and have no meaningful clinical differences compared to their reference biologic.2 They present an opportunity to reduce healthcare costs while maintaining high-quality treatment, especially in oncology.
Are Biosimilars the Same as Generic Drugs?
No, biosimilars are not the same as generic drugs. Generic drugs are identical chemical copies of their brand-name counterparts. Biosimilars are only highly similar to their biologic reference due to the complexity of the molecules involved. Both are used to achieve the same therapeutic effects, but biosimilars are subject to stricter regulations due to their biological variability.
Why Are Biosimilars Important in Cancer Treatment?
Biosimilars are increasingly important in cancer treatment, offering a cost-effective alternative to expensive biologics. In recent years, many biosimilars have been approved for cancer therapies, with regulatory agencies like the FDA and European Medicines Agency (EMA) providing stringent frameworks to ensure their safety and efficacy. The use of biosimilars can reduce the financial burden on patients and healthcare systems without compromising the quality of cancer care.
How Do Biosimilars Work?
Like biologics, biosimilars target specific disease mechanisms in the body, such as blocking cancer cell growth or modulating the immune response in autoimmune conditions. A biosimilar must demonstrate that it is “highly similar with no meaningful clinical differences” to its reference biologic. Regulatory agencies require extensive comparative studies to ensure that biosimilars match their reference products in terms of purity, safety, and effectiveness.
Are Biosimilars Safe?
Yes, biosimilars are safe and effective. In the past decade, many biosimilars have been approved globally, with rigorous testing to ensure they meet the same standards as their reference biologics. Regulatory guidelines demand proof of “no clinical differences” in efficacy, safety, or purity between a biosimilar and its reference biologic.3 Despite their safety, concerns about immunogenicity (the potential to trigger immune reactions) remain a focus of ongoing research.
Challenges in the Adoption of Biosimilars
Despite their promise, several challenges hinder the widespread adoption of biosimilars, including:
- Cost: While biosimilars are generally less expensive than biologics, the production and regulatory approval processes are still costly.
- Immunogenicity: The potential for immune reactions is a primary concern, as these responses can impact a drug’s efficacy.4
- Lack of Awareness: Many patients and healthcare providers are still unaware of biosimilars and their benefits.5
- Extrapolation of Indications: Some biosimilars are approved for multiple uses, even if they have only been tested for one, raising concerns about their effectiveness in other applications.6
- Interchangeability: The ability to switch from a biologic to its biosimilar counterpart without compromising safety or efficacy is still a debated topic in many regions.
Side Effects of Biosimilars
Like biologic drugs, biosimilars can cause side effects, the most common being skin reactions due to intravenous administration.7 Immunogenicity, or the potential for biosimilars to trigger immune system reactions, is considered their primary safety issue.8 While these effects are generally manageable, they can influence the drug’s effectiveness.
The Future of Biosimilars in Oncology
As the number of biosimilars approved for oncology continues to rise, they are poised to become a cornerstone of cancer treatment. Their potential to reduce healthcare costs while delivering the same therapeutic benefits as biologics makes them attractive to healthcare providers and policymakers. However, ongoing efforts are needed to address the challenges of immunogenicity, patient awareness, and regulatory approval processes.
Biosimilars represent a significant advancement in medical treatment, particularly for cancer patients. While their adoption faces hurdles, their ability to provide cost-effective, high-quality alternatives to biologics offers hope for better, more accessible healthcare worldwide.
References
1. Landgraf W, Sandow J. Recombinant human insulins – clinical efficacy and safety in diabetes therapy. European endocrinology. March 2016. Accessed September 7, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813452/.
2. Biosimilars in the United States 2020–2024. IQVIA. Accessed September 7, 2024.https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2020-2024.
3. Biosimilars in the United States 2020–2024. IQVIA. Accessed September 7, 2024.https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2020-2024.
4. Cook JW;McGrath MK;Dixon MD;Switchenko JM;Harvey RD;Pentz RD; Academic oncology clinicians’ understanding of biosimilars and information needed before prescribing. Therapeutic advances in medical oncology. Accessed September 7, 2024. https://pubmed.ncbi.nlm.nih.gov/30671144/.
5. Farfan-Portet M-I, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? – the European Journal of Health Economics. SpringerLink. November 23, 2013. Accessed September 7, 2024. https://link.springer.com/article/10.1007/s10198-013-0538-4.
6. Tesser JR, Furst DE, Jacobs I. Biosimilars and the extrapolation of indications for inflammatory cond: BTT. Biologics: Targets and Therapy. February 17, 2017. Accessed September 7, 2024. https://www.dovepress.com/biosimilars-and-the-extrapolation-of-indications-for-inflammatory-cond-peer-reviewed-fulltext-article-BTT.
7. Yabroff KR, Lund J, Kepka D, Mariotto A. Economic burden of cancer in the United States: Estimates, projections, and future research. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. October 2011. Accessed September 7, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3191884/.
8. Liu PM;Zou L;Sadhu C;Shen WD;Nock S; Comparative immunogenicity assessment: A critical consideration for biosimilar development. Bioanalysis. Accessed September 7, 2024. https://pubmed.ncbi.nlm.nih.gov/25697194/.
