Biologics vs Biosimilars: Understanding the differences
With the potential to offer targeted therapies and reduced side-effects, the drive towards biologics is exciting. Biologics have revolutionized the prevention, diagnosis, and treatment of cancer, autoimmune conditions, and other diseases. Biosimilars have the potential to enhance treatment accessibility, and with biologic patents beginning to expire, this is an interesting era for the two treatment options.1
What are Biologics?
Biologics such as some vaccinations have been around since the 19th century, and in 1982 the U.S. Food and Drug Administration (FDA) approved the first bacteria-generated biologic — human insulin.2 Biologic drugs contain components from living organisms such as humans, plants, animals, and microorganisms.3
Examples of biologics include:
Vaccines (e.g., the human papillomavirus vaccine designed to prevent cervical cancer)
Blood and blood products (e.g., platelets)
Gene therapies (Gene therapy involves replacing a faulty gene or adding a new gene to try and cure a disease or help your body fight disease.)
Tissues for transplant (e.g., tendons and ligaments)
Recombinant proteins (e.g., insulin)
Stem cell therapies (used for certain genetic diseases or cancers)
Monoclonal antibodies (e.g. ones which enhance the natural immune system functions to fight cancer or treat autoimmune diseases)
Biologics differ from traditional pharmaceutical drugs as they come from living organisms. They have a more complex structure, larger molecules, and are not easily reproduced.
What Conditions Can Biologics Treat?
Biologics have been around for a long time and are not a new concept. Modern recombinant DNA-Technology produced biologics have been used in the treatment of some diseases since the 1980s. 8 However, over the years as the knowledge or biologics has advanced, and they have become significant in the treatment of autoimmune diseases, cancer, and genetic conditions. The range of biologics has vastly increased and now includes treatments for the following conditions:
Immune-mediated diseases including diabetes, ankylosing spondylitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, multiple sclerosis, systemic lupus erythematosus, Crohn's disease, and ulcerative colitis.4
Specific cancers including leukemia, lymphoma, gastric, breast, and colon cancer. 5
Rare genetic disorders such as sickle cell disease, hemophilia, Gaucher disease, and cystic fibrosis. 6
Biologics and Cancer
Biological therapy provides a targeted and individualized approach that has revolutionized oncology treatment.8 Cancer cells have ways to avoid destruction by the immune system, and immunotherapy through biologics stimulates the immune system to target and attack cancer cells.7 Put simply, it supports the body’s own immune system to fight cancer cells.
Although not as common as chemotherapy and radiation therapy, biologic therapy has been shown in some types of cancer to target, destroy, and stop the spread of cancer cells, and possibly have fewer side effects than traditional cancer treatments. There are biologics that have been developed to slow down the growth of tumors. The introduction of biologic therapies has provided a course of treatment for some types of advanced or metastatic tumors, before which there was no effective treatment.8
What are Biosimilars, and How are They Different From Biologics?
Due to the high cost of biologics, new legislation was introduced to enable biosimilar production to provide more treatment options, increase access, and lower cost9. Once regulatory exclusivity and intellectual property considerations are addressed for a biologic, manufacturers can seek approval to market a highly similar version of the original biologic drug - known as a biosimilar.
The FDA requires that biosimilar products are highly similar to the original “reference product”. To be approved for use in the U.S., manufacturers must prove that biosimilars:
Work the same way, have the same strength and dosage, and, therefore, can be taken the same way as the original biologic medication.
Do not have any clinically meaningful differences in safety or effectiveness compared to the original biologic medication.
Have the same high standards of manufacturing as the original products.
Biosimilar development saves time and resources by avoiding unnecessary duplication of clinical trials9.
The Difference Between Biosimilars and Generic Medicines
Biosimilars are not exact copies, rather highly similar to the active ingredient of the reference biologic, making them different from generic drugs. 11 Generic medicines are comprised of small molecules and are easy to copy and reproduce. The active ingredient of a generic drug is the same active ingredient of a brand name drug.10 Biosimilars, like all biologics, are subject to inherent minor variability and may have minor differences in clinically inactive components, but are highly similar to the original product.11 Both biosimilar and generic drugs offer a potentially more affordable treatment option for some patients.
The Future of Biologics and Biosimilars
There is no doubt that biologics have transformed the treatment of cancers, autoimmune disorders, and genetic conditions, positively changing many people's futures. Whether treatment is in the form of a biologic or a biosimilar, the FDA's standards for drug approval means that no compromise is made in the product's safety, quality, or efficacy. Regardless of which type of treatment is used, both revolutionary solutions point to exciting future developments in the treatment of cancer and other complex diseases.
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- Targeted Cancer Therapies Fact Sheet. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet. Published 2020. Accessed November 3, 2020.
- Sun W, Zheng W, Simeonov A. Drug discovery and development for rare genetic disorders. American Journal of Medical Genetics Part A. 2017;173(9):2307-2322. doi:10.1002/ajmg.a.38326. Accessed November 3, 2020.
"Immunotherapy For Cancer". National Cancer Institute, 2020, https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed 18 Oct 2020.
Falzone, Luca et al. "Evolution Of Cancer Pharmacological Treatments At The Turn Of The Third Millennium". Frontiers In Pharmacology, vol 9, 2018. Frontiers Media SA, doi:10.3389/fphar.2018.01300. Accessed 18 Oct 2020.
"About Biosimilars And Interchangeable Products". U.S. Food And Drug Administration, 2020, https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#biosimilar. Accessed 18 Oct 2020.
- Overview & Basics. U.S. Food and Drug Administration. https://www.fda.gov/drugs/generic-drugs/overview-basics. Published 2020. Accessed November 3, 2020.
- van de Vooren K, Curto A, Garattini L. Biosimilar Versus Generic Drugs: Same But Different?. Appl Health Econ Health Policy. 2015;13(2):125-127. doi:10.1007/s40258-015-0154-9. Accessed November 3, 2020.
"Biosimilar Cost Savings In The United States". Rand.Org, 2020, https://www.rand.org/pubs/periodicals/health-quarterly/issues/v7/n4/03.html. Accessed 18 Oct 2020.
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Kim, H., Alten, R., Avedano, L. et al. “The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases”. Drugs 80, 99–113 (2020). https://doi.org/10.1007/s40265-020-01256-5. Accessed 18 Oct 2020.
- Raychaudhuri S, Raychaudhuri S. Biologics : Target - specific treatment of systemic and cutaneous autoimmune diseases. Indian J Dermatol. 2009;54(2):100. doi:10.4103/0019-5154.53175