Biologic drugs play a crucial role in the treatment of many important diseases and disorders, but as the patent protection period for many well-known products draws to a close, new versions of biosimilars could revolutionize healthcare systems around the world.

What is a biosimilar medicine?
Biologic drugs, sometimes referred to as biologics, are used to treat chronic diseases 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) from cells or living organisms, and are transformed into medicine by biotechnological techniques.

When the patents and exclusivity periods for these drugs expire, new versions can be developed and distributed using the brand name drug as a model, known as the “reference drug”. 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 very similar but may include some variations. This is because biological drugs are developed from living organisms, the complexity of which does not allow manufacturers to create identical versions, even among batches of different reference drugs.

These medicines are completely legal and the differences between the biosimilar medicine and the reference medicine have not been shown to affect its quality, safety or effectiveness. In 2005, the European Medical Agency pioneered the regulation of biosimilar medicines and has since created a strong set of guidelines to compare biosimilars to the reference product. The use of biosimilars in the UK must be approved and authorized in the same way as all medicines and include quality studies, non-clinical studies and clinical trials in humans.

Why are they important?
Biologics are among the most expensive drugs currently available on the world market. When a new drug is developed, it goes through a period of patent protection that allows the manufacturer to recover the cost of its research and development. This increases the initial price of new drugs and often presents a barrier to patient access, despite the power of many biologic drugs to treat diseases that were previously incurable.

Biosimilars, on the other hand, reduce spending for consumers and introduce more competition into the market. Although these drugs do not offer as much price reduction as traditional generic drugs, they are nevertheless more affordable than the reference drug. This means they are easier to access for patients while expanding the treatment options available to many healthcare systems around the world.

With more biosimilar options becoming available to medical services, it is likely that more patients established on existing biologic drugs will have the opportunity to switch to alternative versions in the future. If a patient switches from a biologic drug to a biosimilar version (which always happens in consultation with a clinician), they are unlikely to notice a difference, as their body should respond in the same way to the alternative drug.

What impact will they have on the health sector?
In the coming years, the market for biologics will become increasingly complex as patent protection for many products has expired or is expected to expire in the near future, and more biosimilar versions emerge for purchase. According to NHS England: “Biologics are the biggest cost and cost growth areas in the NHS medicines budget right now. Until recently, “six of the 10 top-spent drugs prescribed in NHS hospitals” were biologics. By switching patients from an established biologic to a biosimilar version, the NHS could save hundreds of millions of pounds per year.

This means that healthcare providers must adapt to the availability of new drugs. The NHS has made it clear that it will support the appropriate use of the most cost-effective biologics, including biosimilars, which will further stimulate 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 for the treatment of spinal muscular atrophy.

What biosimilar drugs are currently available?
Biosimilar medicines have been used to treat a variety of diseases and conditions for over 14 years. Lately these include Herzuma, Trazimera and Ontruzant, biosimilar versions of the biologic drug trastuzumab, which is a targeted drug used to treat breast cancer and stomach cancer. Then there is Truxima, a biosimilar version of rituximab, which is often used to treat chronic lymphocytic leukemia and non-Hodgkin lymphoma. Since 2015, the NHS also offered Abasaglar, a biosimilar to Lantus (insulin glargine), which is used to treat diabetes.

In June 2021, the National Institute for Health and Excellence in Care (Nice) approved for use new biologic drugs for the treatment of 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 to only severe patients in the past. This is a particularly important 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 that they can avoid irreversible joint damage.

Etanercept biosimilar has reached a milestone: Etanercept is the most widely prescribed biologic medicine for rheumatoid arthritis and its biosimilar version is now more prescribed than the reference medicine in the UK and EU . In addition, the biosimilars 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 are biosimilar drugs not better known?
When the first biosimilars hit the market around 14 years ago, many regulators and clinicians were unsure of their effectiveness and safety. This meant that they weren’t initially something that gained wide attention outside of medical circles. Since then, regulators and industry practitioners have worked hard to educate healthcare professionals, including nurses, which has raised awareness of their potential. Confidence in these drugs has grown steadily over the past five years, bringing with it a better understanding and appreciation of the therapeutic capabilities and cost-benefit of biosimilars.

To learn more about biosimilars and their potential to transform the way biologic therapies are delivered to patients, visit Samsung Bioepis