Biological medications play a crucial role in the treatment of many significant diseases and disorders, but as the period of patent protection for many known products comes to an end, new biosimilar versions could revolutionise healthcare systems across the world.
What is biosimilar medication?
Biological medicines, sometimes referred to as biologics, are used to treat chronic conditions such as rheumatoid arthritis, inflammatory bowel disease (IBD), cancer, psoriasis, and multiple sclerosis, among others. They contain active substances derived from biological sources (often proteins) taken from living cells or organisms, and are manufactured into medicine through biotechnological techniques.
When the patents and periods of marketing exclusivity for these medicines expire, newer versions can be developed and distributed using the original drug as a template, what is known as the “reference medicine”. But while a “generic medicine” is an identical replica of a reference medicine, such as a supermarket-bought ibuprofen which is a generic version of Nurofen, biosimilar medicines are highly similar but may include some variations. This is because biological medicines are developed from living organisms, the complexities of which make it impossible for manufacturers to create identical versions, even among different reference medicine batches.
These medicines are completely legal and any differences between the biosimilar and reference medicine are not shown to affect its quality, safety or efficacy. In 2005, the European Medical Agency pioneered the regulation of biosimilar medicines and has since created a robust set of guidelines for comparing biosimilars to the reference product. The use of biosimilars in the UK must be approved and licensed in the same way as all medicines and include quality studies, non-clinical studies, and human clinical trials.
Why are they important?
Biological medicines are among the most expensive medicines currently available on the world market. When a new medicine is developed, they are subjected to a period of patent protection that allows the manufacturer to recover the cost of their research and development. This increases the initial price of new medicines and often presents a barrier to patient access, despite the power of many biological medicines to treat diseases that were previously untreatable.
Biosimilar medicines, on the other hand, reduce the expense for consumers and introduce more competition to the market. Although these drugs may not offer as great a price reduction as traditional generic medicines, they are nevertheless more affordable than the reference drug. This means they are easier for patients to access while also expanding the treatment options available for many healthcare systems across the world.
With more biosimilar options becoming available to medical services, it is likely that greater numbers of patients established on existing biological medications will be given the option to switch to alternative versions in the future. If a patient is moved from a biological drug to a biosimilar version (something that always occurs in consultation with a clinician), they are unlikely to notice a difference, as their body should respond to the alternative drug in the same way.
What impact will they have on the healthcare industry?
In the coming years, the market for biological medicines will become increasingly complex as patent protection for many products has either expired or is expected to expire in the near future, and more biosimilar versions emerge for purchase. According to NHS England: “Biological medicines are currently the largest cost and cost growth areas in the NHS medicines budget.” Until recently, “six of the top 10 medicines by spend prescribed in NHS hospitals” were biological products. By switching patients from an established biological drug to a biosimilar version, the NHS could save hundreds of millions of pounds per year.
This means healthcare providers are having to adapt to the availability of new medicines. The NHS has made it clear that it will support the appropriate use of the best-value biological medicines, including biosimilars, which will stimulate more competition to create cost-effective treatments and give patients access to new and innovative medicines. An example of the latter is the use of Zolgensma in treating spinal muscular atrophy.
What biosimilar medications are currently out there?
Biosimilar medicines have been used to treat a range of diseases and conditions for more than 14 years. Latterly, these include Herzuma, Trazimera and Ontruzant, biosimilar versions of the biological medicine trastuzumab, which is a targeted drug used to treat breast cancer and stomach cancer. Then there is Truxima, one biosimilar version of rituximab, which is often used to treat chronic lymphocytic leukaemia and non-Hodgkin lymphoma. Since 2015, the NHS has also been offering Abasaglar, a biosimilar to Lantus (insulin glargine), which is used in the treatment of diabetes.
In June 2021, the National Institute for Health and Care Excellence (Nice) approved the use of new biological medicines for treating moderate rheumatoid arthritis, which include biosimilars for adalimumab, etanercept, and infliximab. Now, patients with severe to moderate rheumatoid arthritis can be treated with biosimilars, compared with only severe patients in the past. This is a particularly significant development as it offers new treatment options for patients who have not responded well to intensive therapy using traditional disease-modifying anti-rheumatic drugs. Early and timely biological treatment of patients means they may avoid irreversible joint damage.
The biosimilar for etanercept has achieved a major milestone – etanercept is the most widely prescribed biologic for rheumatoid arthritis and its biosimilar version is now more prescribed than the reference medicine in the UK and the European Union. In addition, the biosimilars for adalimumab and infliximab can also be used to treat a range of other inflammatory diseases, such as Crohn’s disease, ulcerative colitis and psoriasis.
Why isn’t biosimilar medication more widely known?
When the first biosimilars emerged on to the market about 14 years ago, many regulators and clinicians were unsure about their efficacy and safety. This meant they were not initially something that caught widespread attention outside of medical circles. Since then, regulatory agencies and industry practitioners have been working hard to educate healthcare professionals, including nurses, and this has raised awareness of their potential. Confidence in these medications has been growing steadily over the past five years, bringing with it a greater understanding and appreciation of the therapeutic capabilities and cost benefits of biosimilars.
To learn more about biosimilars and their potential to transform the way biologic therapies are brought to patients, visit Samsung Bioepis
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