A Step Forward in Modern Healthcare: Addressing the High Costs of Biologics in Society
Biologics are a class of medications derived from a complex combination of living organisms and their associated products such as cells and tissues. Biologics rose to popularity following improvements in recombinant DNA technology—the process of combining DNA from different sources for a therapeutic outcome—in the 1980s, with artificial human insulin being introduced in 1982 to treat diabetes.[1] This was followed by the development of artificially synthesized antibodies called Monoclonal Antibodies (mAbs) in the 1990s, and eventually gene and cell therapy in the 2010s.
Biologics exhibit massive potential in treating complex diseases that pharmaceutical medication has not been able to. Keytruda ®, a biological drug used to treat Melanoma, facilitates immune cells to recognize and kill cancer cells.[2] Based on a prospective study over 10 years that assessed the ability of the drug to prolong lifespan, 34% of the patients lived post-treatment, with death rates reduced by 29%. [3] In comparison, chemotherapy, a non-biologic form of cancer treatment, did not demonstrate effective treatment as the melanoma was resistant to the chemotherapeutic agents. [4]
Biologics also have a significant role in treating auto-immune diseases. Known to reduce symptoms and slow disease progression, Humira ®, is a biologic drug used for Rheumatoid Arthritis (RA). A study assessing the efficacy of the drug demonstrated a 23% remission rate when used alone and double of that when used in combination with other drugs. [5] In comparison, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), the most prescribed type of non-biologic medication for RA, reduced inflammation and pain. Symptoms were thereby alleviated, but did not slow down disease progression. These examples demonstrate evidence that biologics have potential to cure what existing pharmaceutical drugs cannot.
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Secondly, biologics are highly targeted and precise medications. Treatment with pharmaceutical drugs can often result in adverse side effects as drug interactions are not completely regulated. By contrast, biologics are designed to target specific components in the body, minimizing the risk of side effects. This specificity also enables optimal therapy in the first attempt. For instance, Herceptin® is a biological drug that specifically targets the HER2 receptor and has shown to reduce the recurrence of breast cancer as a result.
By showing such significant promise, biologics appear as a stepping stone in precision medicine, providing hope where traditional treatments tend to fall short. The question remains, why is the prevalence of these diseases still high, despite having such an ideal solution? The answer is simple: biologics are barely affordable. Depending on the complexity of the disease, the cost of biologics can range from £10,000 to £30,000 a year. [6]
What leads to the high costs of biologics? Firstly, they are complex to manufacture because of their intricate molecular structure. This complexity also makes it challenging to reproduce the drug batch, resulting in a limited competition and high prices. Companies leverage on this limited competition to generate a revenue.[7] When marketing the drug Humira®, the pharmaceutical company established a ‘patent thicket’, where they accumulated multiple patents to maintain market exclusivity and the limited competition to keep the prices hiked. [8] As a result, Humira® costs up to £3500 per patient per year.
The challenge to reproduce the drug batch also raises questions regarding its safety, leading to more stringent checks, thereby increasing the price in overall research and development.
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Several interventions have been implemented to address the high costs, but each have their own limitations that urges authorities in power to seek for more viable solutions.
Biosimilar drugs—a cheaper mimic of the original biologic—were introduced into the market in attempts to reduce overall costs. [9] For instance, the biosimilar equivalent of Humaira ®, Imraldi ®, showed similar clinical efficacy to the biologic. As an efficient and cheaper alternative, it seemed like a viable solution up until several concerns were raised regarding its safety. This is because the regulatory checks focused on assessing its similarity to the biologic and not the safety of the drug itself.
Additionally, various government and assistant schemes have been introduced to help cope with the high costs. In the UK, NHS covers the cost of treatment if approved by the National Institute for Health and Care Excellence (NICE). Further, specific patient assistance programs have been established to help with the costs. [10] A case in point would be the Adbry Advocate Program, which helps individuals with atopic dermatitis to afford their treatment. [11] Within this program, there are multiple subprograms that either subsidize or completely cover the costs of the treatment. However, these schemes are limited in several ways. Firstly, patients still must incur out-of-pocket expenses such as deductibles and co-payments, which still bring up the price to an unaffordable amount. Secondly, with a high demand of patients requiring biologics treatment, it can be both challenging and time-consuming to provide coverage for everyone, limiting the accessibility of the drug even if it is cheaper.
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The current solutions, though flawed, have potential to drastically lower cost barriers if it is fine-tuned. Pharmaceutical companies and other regulatory bodies involved in approving biosimilars should implement more checks that account for both drug safety and similarity to the biologic. As such, biosimilars would be a cheaper, effective and safer alternative to biologics. Further, insurance and payment schemes should be altered to cover more of the additional costs, aiming to reduce the financial burden caused by it.
From a biological perspective, improvements could be made in ensuring more efficient drug manufacturing. Artificial Intelligence (AI) could be used to conduct more large-scale and less time-consuming pre-clinical, clinical and post-clinical studies, as it can be used to focus on the right patient populations and predict trial outcomes. This significantly reduces costs put into research and development. AI models can also be used to predict drug efficacy and safety, optimizing the treatment plan.
Given the impact of biologics in putting an end to life-threatening diseases and significantly improving healthcare outcomes in society, it is unfortunate that the major reason why biologics is not viable is its economic limitations, and not scientific progress or the lack thereof. If biotechnology has come this far in providing hope for cure, more needs to be done in addressing cost barriers pertaining to biologics.
References:
Kalal BS, Upadhya D and Pai VR, ‘Chemotherapy Resistance Mechanisms in Advanced Skin Cancer’ (2017) 11 Oncology Reviews
Modi J, ‘Why Are Biologics so Expensive? - BuzzRx’ (BuzzRx6 September 2022) <https://www.buzzrx.com/blog/why-are-biologics-so-expensive#> accessed 26 March 2025
Malaviya A and Mehra N, ‘A Fascinating Story of the Discovery & Development of Biologicals for Use in Clinical Medicine’ (2018) 148 Indian Journal of Medical Research 263
NA, ‘Immunotherapy for Metastatic Melanoma - Pembrolizumab, Keytruda - MRA’ (Curemelanoma.org2025) <https://www.curemelanoma.org/patient-eng/melanoma-treatment/options/keytruda-pembrolizumab> accessed 26 March 2025
NA , ‘Ten-Year Data for Merck’s KEYTRUDA® (Pembrolizumab) Demonstrates Sustained Overall Survival Benefit versus Ipilimumab in Advanced Melanoma - Merck.com’ (Merck.com13 October 2024) https://www.merck.com/news/ten-year-data-for-mercks-keytruda-pembrolizumab-demonstrates-sustained-overall-survival-benefit-versus-ipilimumab-in-advanced-melanoma/
NA, ‘The Real Cost of Biologic Drugs’ (Biologic Medications22 November 2024) <https://biologicmeds.org/biologic-basics/the-real-cost-of-biologic-drugs/?utm_source=chatgpt.com> accessed 26 March 2025
NA , ‘LEO Pharma’ (Adbry.com2024) <https://www.adbry.com/savings-and-support-programs/adbry-advocate> accessed 26 March 2025
Welch B, ‘Adalimumab (Humira) for the Treatment of Rheumatoid Arthritis’ (2008) 78 American Family Physician 1406
[1] Anand N Malaviya and Narinder K Mehra, ‘A Fascinating Story of the Discovery & Development of Biologicals for Use in Clinical Medicine’ (2018) 148 Indian Journal of Medical Research 263.
[2] NA , ‘Immunotherapy for Metastatic Melanoma - Pembrolizumab, Keytruda - MRA’ (Curemelanoma.org2025) <https://www.curemelanoma.org/patient-eng/melanoma-treatment/options/keytruda-pembrolizumab> accessed 26 March 2025.
[3] NA , ‘Ten-Year Data for Merck’s KEYTRUDA® (Pembrolizumab) Demonstrates Sustained Overall Survival Benefit versus Ipilimumab in Advanced Melanoma - Merck.com’ (Merck.com13 October 2024) <https://www.merck.com/news/ten-year-data-for-mercks-keytruda-pembrolizumab-demonstrates-sustained-overall-survival-benefit-versus-ipilimumab-in-advanced-melanoma/>.
[4] Bhuvanesh Sukhlal Kalal, Dinesh Upadhya and Vinitha Ramanath Pai, ‘Chemotherapy Resistance Mechanisms in Advanced Skin Cancer’ (2017) 11 Oncology Reviews.
[5] Beth Welch, ‘Adalimumab (Humira) for the Treatment of Rheumatoid Arthritis’ (2008) 78 American Family Physician 1406 <https://www.aafp.org/pubs/afp/issues/2008/1215/p1406.html?utm_source=chatgpt.com> accessed 26 March 2025.
[6] Juhi Modi, ‘Why Are Biologics so Expensive? - BuzzRx’ (BuzzRx6 September 2022) <https://www.buzzrx.com/blog/why-are-biologics-so-expensive#> accessed 26 March 2025.
[7] Ibid
[8] Ryan Knox and Gregory Curfman, ‘The Humira Patent Thicket, the Noerr-Pennington Doctrine, and Antitrust’s Patent Problem’ [2022] SSRN Electronic Journal.
[9] NA , ‘The Real Cost of Biologic Drugs’ (Biologic Medications22 November 2024) <https://biologicmeds.org/biologic-basics/the-real-cost-of-biologic-drugs/?utm_source=chatgpt.com> accessed 26 March 2025.
[10] Ibid
[11] NA , ‘LEO Pharma’ (Adbry.com2024) <https://www.adbry.com/savings-and-support-programs/adbry-advocate> accessed 26 March 2025.