Biosimilars: Transforming Patient Care in Oncology and Immunology

By Dara Shahrokh Ph.D., Medical Advisor, Pharmaceuticals

The introduction of biosimilars has represented a significant leap forward in the global healthcare landscape, particularly in oncology and immunology. Biosimilars, which are biological medicines designed to be highly similar to the reference biological medicines have revolutionized patient care by improving access, reducing costs, and driving innovation. As the prevalence of cancer and autoimmune diseases rises globally, the demand for effective and affordable treatments grows, making biosimilars an increasingly critical component of modern medicine. This article explores how biosimilars transform patient care globally, focusing on their impact on oncology and immunology.

The Basics of Biosimilars

As their name suggests, biologics are made with biological materials, including materials from humans, animals, and microorganisms. These molecules go through a rigorous, tightly controlled manufacturing process and tend to be patented. As their patents expire, the field opens to biosimilars. Unlike generics, biosimilars are not identical to their reference biologic due to the complex nature of biologic drugs. Still, they are required to demonstrate no clinically meaningful differences in safety, purity, and efficacy compared to their reference products. Regulatory agencies, such as the FDA in the United States and the EMA in Europe, have stringent approval processes to ensure the reliability of biosimilars. These rigorous standards foster confidence among healthcare providers and patients, facilitating the integration of biosimilars into treatment regimens.

Enhancing Access to Treatment

One of the most transformative impacts of biosimilars is their ability to enhance access to life-saving treatments. Biologic drugs have revolutionized the management of cancer and autoimmune diseases but are often prohibitively expensive. In many low- and middle-income countries, the cost of biologics places them out of reach for most patients, leading to disparities in care. Biosimilars, being more affordable, bridge this gap and allow more patients to benefit from advanced therapies.

For instance, in oncology, monoclonal antibodies such as trastuzumab and rituximab are essential for treating certain types of cancer, including breast cancer and non-Hodgkin’s lymphoma. The introduction of biosimilars for these drugs has expanded access to effective treatments, particularly in resource-limited settings. Similarly, in immunology, biosimilars of drugs like infliximab and adalimumab have enabled broader access to treatments for diseases such as rheumatoid arthritis, Crohn’s disease, and psoriasis. Currently, many more Biosimilars are coming to market, and even innovator companies like Pfizer, AMGEN, and MERCK have invested in the Biosimilar space.

Cost Savings and Economic Impact

The cost savings associated with biosimilars extend beyond individual patients to entire healthcare systems. By introducing competition into the biologics market, biosimilars drive down prices, allowing healthcare providers to allocate resources more effectively. This is particularly important in oncology and immunology, where the cost of treatments can strain even the most robust healthcare systems.

A study by the IQVIA Institute for Human Data Science estimated that biosimilars could generate savings of up to $160 billion globally between 2020 and 2024. These savings can be reinvested into healthcare systems to improve infrastructure, fund research, and expand access to other medical services. For patients, reduced costs mean fewer financial barriers to receiving timely and appropriate care, which can lead to better health outcomes.

Driving Innovation

While biosimilars are fundamentally based on existing biologics, their development requires advanced scientific and technological capabilities. The production of biosimilars necessitates a deep understanding of biologic manufacturing processes, as well as significant investment in research and development. This drive for innovation not only ensures the quality of biosimilars but also fosters advancements in biotechnology.

Moreover, the competitive environment created by biosimilars encourages original biologic manufacturers to innovate further. To maintain market share, these companies may invest in improving existing drugs, exploring novel delivery mechanisms, or developing new therapies and pathways such as check-point inhibitors in Oncology and the JAK Kinase Inhibitors in Immunology. This dynamic benefits patients by accelerating the availability of cutting-edge treatments.

Impact on Oncology and Immunology

In oncology, the availability of biosimilars has allowed healthcare providers to treat more patients without compromising on the quality of care. For example, biosimilars of trastuzumab have been widely adopted in the treatment of HER2-positive breast cancer, offering comparable efficacy at a reduced cost.

The use of biosimilars in supportive cancer care is another area of significant impact. Drugs like filgrastim and pegfilgrastim, which are used to prevent infections in chemotherapy patients, have more affordable biosimilar counterparts. This has enabled wider use of prophylactic treatments, reducing the risk of complications and improving patient outcomes.

In the field of immunology, biosimilars are transforming the management of chronic and often debilitating conditions. Autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease require long-term treatment with biologics to manage symptoms and prevent disease progression. The high cost of biologics has historically limited their use, leaving many patients under-treated.

The introduction of biosimilars for tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab, has significantly expanded access to treatment. Patients who previously could not afford these therapies now have the opportunity to achieve better disease control and improved quality of life. In addition, the manufacturers of biosimilars have gone a step further by introducing novel delivery methods such as the subcutaneous injection for Infliximab instead of the intravenous route (IV) to enhance patients’ experience, or new formulations such as the high-concentration citrate-free Adalimumab which causes less injection site pain in patients, leading to improved adherence rates and potentially better patient outcome. 

Challenges and Opportunities

Despite their numerous benefits, the adoption of biosimilars is not without challenges. Skepticism among healthcare providers and patients regarding the efficacy and safety of biosimilars remains a barrier. Education and awareness campaigns are essential to address these concerns and build trust in biosimilars.

Another challenge is the regulatory landscape, which varies across regions. Harmonizing regulatory standards globally could streamline the approval process and facilitate broader access to biosimilars. Additionally, policies that incentivize the use of biosimilars, such as reimbursement frameworks and prescribing guidelines, can further drive their adoption.

Opportunities for biosimilars lie in ongoing advancements in biotechnology and manufacturing processes. As technologies improve, the production of biosimilars is likely to become even more efficient, reducing costs further and increasing accessibility. Furthermore, the expansion of biosimilars into new therapeutic areas holds promise for addressing unmet medical needs.

Conclusion

Biosimilars are transforming patient care globally, and the impact is evident in the improved quality of life for patients, the economic benefits for healthcare systems, and the fostering of a competitive and innovative pharmaceutical industry. While challenges remain, the continued growth and adoption of biosimilars offer a path toward more equitable and sustainable healthcare. As the global burden of cancer and autoimmune diseases continues to rise, biosimilars offer a crucial solution by making cutting-edge treatments more accessible and affordable, ultimately enhancing clinical outcomes in patients.

References:

1. Gely C, Marín L, Gordillo J, Mañosa M, Bertoletti F, Cañete F, González-Muñoza C, Calafat M, Domènech E, Garcia-Planella E. Impact of pain associated with the subcutaneous administration of adalimumab. Gastroenterol Hepatol. 2020 Jan;43(1):9-13.
2. Priyaregaa, Sivakumar and Ramanathan Natarajanb. An overview of biosimilars for cancer, diabetes mellitus, rheumatoid arthritis and other immune-mediated diseases approved between 2016 and 2021. Results in Chemistry. https://doi.org/10.1016/j.rechem.2022.100356. Published April 29, 2022. Accessed September 9, 2022.
3. Targeted cancer therapies. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet. Last updated October 25, 2021. Accessed October 27, 2021.
4. Eisenstein M. Bring on the biosimilars. Nature. 2019;569:S2-S3. https://www.nature.com/articles/d41586-019-01401-5. Published May 8, 2019. Accessed October 27, 2021.
5. Biosimilar and interchangeable products. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Last updated October 23, 2017. Accessed October 27, 2021.
6. Nash P, Vanhoof J, Hall S, Arulmani U, Tarzynski-Potempa R, Payne AN, Cividino A. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2016 Dec; 3(2): 257–270.