Rheumatoid arthritis is a common autoimmune disease known to cause pain, inflammation, and even deformities in the joints. It most commonly impacts joints including the fingers, knees, and elbows. This comes as a result of the body’s immune system mistakenly attacking the synovial—the membrane that lines the joint cavities. While rheumatoid arthritis is often associated with joint pain, it can also affect the eyes and lungs and even lead to kidney disease in some instances.
Worldwide, about 18 million people—an estimated 70 percent of which are women—are impacted by rheumatoid arthritis. And while rheumatoid arthritis is currently incurable, it is treatable. One of the most commonly prescribed rheumatoid arthritis treatments is methotrexate, which reduces inflammation and consequently minimizes joint pain. Yet, some rheumatoid arthritis patients do not respond to methotrexate, further complicating their treatment options.
Patients unresponsive to methotrexate sometimes turn to leflunomide, an immunosuppressive drug that, like methotrexate, can reduce inflammation and joint pain for those with rheumatoid arthritis. However, treatment with leflunomide also comes with a significant healthcare cost.
For this reason, some rheumatoid arthritis patients are considering the use of biosimilars to treat their disease.
What Are Biosimilars?
As their name suggests, biosimilars are biological medications made from living cells that are similar to other FDA-approved drugs, referred to as reference products. They yield similar results to reference products but are sometimes considerably more affordable.
A recent study conducted on over 25,000 rheumatoid arthritis patients from 2000 to 2021 proved that biosimilars may not only be more cost-effective than their reference products, but may also produce improved treatment results.
According to the study, treatment with leflunomide came with a lifetime healthcare cost of $154,632 along with a quality-adjusted life-year (QALY) measurement of 14.82. Meanwhile, patients treated with biosimilar adalimumab not only reaped the benefits of a lifetime health care cost of $145,419—over $9,000 of savings compared to those treated with leflunomide —but also saw a QALY estimate boosted to 15.55.
Treatment with biosimilar infliximab was also more cost-effective than leflunomide while showing a considerable uptick in QALY (15.35).
Biosimilars vs. Generic Drugs
Given those impacts, it’s critical to understand how biosimilars are different from the generic medications we often prescribe to our patients.
Here are some key differences between the two:
- Generic medications are chemically engineered from brand-name drugs. Biosimilars are made from living cells.
- Generic medications require an abbreviated new drug application (ANDA) in order to gain FDA approval. Biosimilars require a 351(k) application for approval.
- While both generics and biosimilars are typically less expensive than brand-name drugs, generics are often cheaper than biosimilars.
The Future of Biosimilars
It wasn’t until 2015 that a biosimilar was officially approved by the FDA. Now, 60 biosimilars have gained FDA approval, and that number figures to grow considerably. Thanks to their positive impact on the pharmaceutical market, along with their safety and efficacy, biosimilars are expected to play an integral role in shaping the future of how patients across the world are treated.
References:
Kuan Peng, M. (2024, June 26). Cost-effectiveness of biosimilars vs leflunomide in patients with rheumatoid arthritis. JAMA Network Open. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820368
World Health Organization. (n.d.). Rheumatoid arthritis. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis
Lopez-Olivo, M. A., Siddhanamatha, H. R., Shea, B., Tugwell, P., Wells, G. A., & Suarez-Almazor, M. E. (2014, June 10). Methotrexate for treating rheumatoid arthritis. The Cochrane database of systematic reviews. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047041/#:~:text=Methotrexate%20inhibits%20the%20synthesis%20of,of%20rheumatoid%20arthritis%20(RA).
Golshani, S., & Ali Faramarzi, M. (2021, September). Expected impact of biosimilars on the pharmaceutical companies. Iranian journal of medical sciences. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438344/