From Breakthrough to Everyday Treatment: Biologics Revolutionizing Inflammatory Disease Management
Inflammatory diseases (ID) like rheumatoid arthritis, Crohn's disease, and ulcerative colitis have long been a challenge to manage and treat. These conditions, characterized by chronic inflammation and debilitating symptoms, often lead to reduced quality of life, increased risk of serious complications, and significant healthcare costs.
The importance of managing ID’s effectively cannot be overstated, as untreated inflammation can cause severe damage to vital organs and tissues. Enter biologics and biosimilars—a groundbreaking class of drugs that has brought new hope to those living with these challenging conditions.
In this article, we'll talk about biologics, how they work, the benefits they offer to patients, their impact on the treatment of ID, and what the future holds for these treatments. Additionally, we will discuss biosimilars as a cost-effective alternative to biologics, helping to reduce healthcare expenses while maintaining treatment efficacy.
What Are Biologics?
Biological drugs, commonly referred to as biologics, are a diverse group of medications derived from living organisms, such as bacteria, yeast, or mammalian cells. Unlike traditional small-molecule drugs, which are chemically synthesized, biologics are large molecules produced through complex biological processes.
Many biologics target specific components of the immune system, unlike traditional treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or classical disease-modifying anti-rheumatic drugs (DMARDs). These traditional treatments often reduce inflammation more broadly, sometimes leading to broader immune suppression.
By focusing on particular molecules or cells involved in the inflammatory response, biologics can control inflammation with greater precision. This targeted approach is what makes them highly effective in treating various inflammatory diseases.
However, it's important to note that not all biologics work this way—some may act on different pathways depending on the condition they are designed to treat. Additionally, certain biologics, such as biological disease-modifying anti-rheumatic drugs (bDMARDs), offer significant therapeutic benefits, but these are counterbalanced, like all DMARDs, by an increased risk of infections, including bacterial, fungal, and viral infections.
Biologics and Inflammatory Diseases: A Therapeutic Revolution
Biologics are used to treat a wide range of inflammatory and autoimmune diseases because of their ability to specifically target certain molecules and pathways involved in the disease process.
Before biologics were introduced, treatment options for conditions such as rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, and many others relied on the use of NSAIDs, corticosteroids, and DMARDs.
The introduction of biologics represented a major breakthrough in treating inflammatory diseases. While for some conditions, such as rheumatoid arthritis, there is currently no convincing evidence that biologic drugs have superior clinical efficacy over synthetic drugs (csDMARDs) in all cases, biologics are particularly effective for patients with moderate to severe disease who have not responded to or have failed conventional synthetic DMARDs.
In these cases, bDMARDs are often combined with csDMARDs to optimize treatment, as recommended by guidelines from organizations like EULAR and ECCO. Biologics work by blocking specific molecules, such as tumor necrosis factor (TNF) or interleukin-6 (IL-6), which play a role in the inflammatory process, offering a faster onset of action compared to traditional treatments.
Let's take a look at how biologics can be used to treat the most common inflammatory diseases:
Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disorder that primarily affects the joints but can also impact other tissues and organs. It is an autoimmune condition where the immune system mistakenly attacks the body's own tissues, leading to inflammation, swelling, pain, and eventual joint damage.
RA typically manifests as symmetrical joint involvement, meaning it affects both sides of the body equally. Common symptoms include joint stiffness, particularly in the morning or after periods of inactivity, fatigue, and a feeling of warmth in the affected joints. Over time, RA can lead to significant disability, reduced quality of life, and an increased risk of cardiovascular disease.
The impact of RA on a patient's life can be profound. Daily tasks that were once simple can become challenging due to pain and loss of joint function. Many individuals with RA experience difficulty performing activities such as walking, dressing, and gripping objects, which can lead to a decline in independence and emotional well-being. Additionally, chronic pain and fatigue can contribute to mental health issues such as depression and anxiety, further compounding the overall burden of the disease.
Conventional treatments for rheumatoid arthritis, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and traditional disease-modifying antirheumatic drugs (DMARDs) often fall short in controlling disease progression and providing long-term relief. Fortunately, biologics and biosimilars offer a promising alternative for treating RA by offering more targeted and effective disease management.
For instance, biologics such as tumor necrosis factor (TNF) inhibitors, interleukin-6 (IL-6) receptor antagonists,Interleukin-1 (IL-1) blockers, and B-cell depleting agents block inflammatory cytokines and immune cells responsible for causing joint destruction. By doing so, biologics can reduce symptoms, prevent joint damage, and improve physical function.
Additionally, Janus kinase (JAK) inhibitors, while not biologics, represent a newer class of targeted therapies with a similar level of efficacy as biologics. JAK inhibitors interfere with signals in the body that are thought contribute to the inflammatory process in RA.
Clinical studies have demonstrated that treatments with biologic therapies are efficacious in clinical trials for the treatment of RA patients with an inadequate response to synthetic DMARDs. Furthermore, biologic agents can delay radiographic progression, indicating the potential benefits in preventing long-term disability from joint damage in addition to the short-term disability from symptoms of inflammatory arthritis. This represents a significant advancement in the ability to manage RA and improve the quality of life for those affected by this debilitating condition.
Crohn's Disease
Crohn's Disease is a chronic inflammatory condition primarily affecting the gastrointestinal (GI) tract. It is part of a group of conditions known as inflammatory bowel diseases (IBD). The inflammation caused by Crohn's Disease can affect different areas of the digestive tract in different people, often leading to severe discomfort and complications. The precise cause of Crohn's Disease remains unknown, but it is thought to result from a combination of genetic, environmental, and immune system factors.
The symptoms of Crohn's Disease can vary significantly from person to person and depend on the area of the GI tract affected. Common symptoms include persistent diarrhea, abdominal pain and cramping, fatigue, weight loss, and malnutrition. Other symptoms may include rectal bleeding, fever, and a sensation of incomplete bowel evacuation. These symptoms can lead to severe, life-altering disruptions and often fluctuate in intensity, with periods of remission and flare-ups.
The treatment of Crohn's Disease typically involves a combination of medication, lifestyle changes, and sometimes surgery. Medications include anti-inflammatory drugs, corticosteroids, immunomodulators, and antibiotics. These treatments aim to reduce inflammation, manage symptoms, and achieve and maintain remission. However, as with RA, many patients find that these treatments provide only temporary relief. In severe cases, surgical intervention to remove damaged portions of the GI tract becomes necessary.
Clinical studies have shown that biologics can lead to mucosal healing, reduced need for corticosteroids, and decreased risk of hospitalization and surgery. While biologics have represented a significant advancement in the management of inflammatory diseases for over two decades, newer therapies, including small molecule inhibitors, are now emerging and offer additional treatment options. The availability of both biologics and newer therapies provides hope for long-term remission and a better quality of life for those affected by Crohn’s Disease.
Ulcerative Colitis
Ulcerative colitis (UC), another form of IBD, causes chronic inflammation and ulcers in the colon and rectum. It is characterized by the continuous inflammation of the innermost lining of the colon, leading to the formation of ulcers. The symptoms of UC can vary in severity and include abdominal pain, diarrhea often accompanied by blood or pus, weight loss, fatigue, and an urgent need to defecate.
The disease typically follows a pattern of flare-ups followed by periods of remission. The continuous nature of the inflammation distinguishes UC from other forms of inflammatory bowel disease (IBD), such as Crohn's Disease, which can affect any part of the gastrointestinal tract and in a patchy distribution.
Chronic Ulcerative Colitis symptoms can significantly impair daily activities and reduce the overall quality of life. Frequent and urgent bowel movements, alongside persistent abdominal pain and fatigue, can lead to missed work or school, social isolation, and reduced participation in leisure activities. Additionally, the unpredictability of disease flare-ups exacerbates anxiety and stress among patients. Long-term inflammation in UC can also increase the risk of colorectal cancer, necessitating regular monitoring and screening.
First-line treatments for Ulcerative Colitis often comprise aminosalicylates which help to reduce inflammation in the lining of the colon. Corticosteroids may be prescribed for short-term use during severe flare-ups due to their potent anti-inflammatory properties.
Additionally, immunomodulators are used to suppress the immune response. These traditional therapies, while effective for many, may not be sufficient for all patients and often come with side effects that limit their long-term use.
How Biosimilars Differ from Reference Biologics
While original biologic drugs have revolutionized treatment for many conditions, their high cost has limited access for some patients. This is where biosimilars come into play. Biosimilars are nearly identical copies of original biologic drugs, with no clinically meaningful differences in safety, purity, or potency.
For a more interactive understanding of how biosimilars compare to biologics, you can watch these informative videos available in German and French on the Intergenerika website.
If we look at the Swiss law (TPA) definition, a biosimilar product is defined as “a biological medicinal product sufficiently similar to a reference preparation authorized by the Agency and that refers to its documentation.”
Unlike generic drugs, which are exact replicas of their brand-name counterparts and can be used interchangeably, biosimilars may have slight variations from the original biologic drug due to the nature of their production process and the inherent variability of living cells.
To develop a biosimilar, you must demonstrate that it is 'comparable' to its reference product through extensive analytical, non-clinical, and clinical studies, including pharmacokinetic, pharmacodynamic, and phase 3 studies. This ensures the biosimilar exhibits similar safety, purity, and potency as its reference product.
Benefits of Biosimilars for Patients with Inflammatory Diseases
The biologic therapies we've mentioned above are highly effective but can also be costly for patients. This takes us back to biosimilars and their advantages for patients with inflammatory diseases.
This brings us to biosimilars and their significant advantages for patients with inflammatory diseases. Not only are they more affordable, but their safety and efficacy are also recognized by regulatory authorities. In June 2023, Swissmedic updated its guidance on the interchangeability of biosimilars, reaffirming that minor differences in manufacturing do not affect their safety and efficacy compared to the reference product. This update aligns with the European Medicines Agency's (EMA) findings, further solidifying the role of biosimilars in modern healthcare.
Let’s look at several benefits of biosimilars that patients should be aware of:
Cost-Effectiveness and Affordability
One of the most significant advantages of biosimilars is their cost-effectiveness. Biosimilars are developed to be highly similar and clinically equivalent to the reference biologic but at a lower price point. This increased affordability can make life-changing treatments accessible to a broader patient population, reducing financial barriers to care and the overall burden on healthcare systems.
Increased Access to Treatment Options
The introduction of biosimilars has expanded the range of therapeutic options available to patients with inflammatory diseases. With multiple biosimilar products on the market, healthcare providers can tailor treatments to individual patient needs, improving outcomes and enhancing quality of care.
Positive Impact on Healthcare Systems and Patient Outcomes
Biosimilars not only benefit patients but also have a positive impact on healthcare systems as a whole. By reducing treatment costs, biosimilars can help alleviate the financial burden on healthcare providers and payers, allowing for more efficient allocation of resources and improved patient care.
For instance, in Switzerland, the integration of biosimilars and generics led to savings of approximately 679 million CHF in 2023. However, according to the Intergenerika Biosimilars Report, Switzerland still missed out on potential savings of 90 million CHF due to a continued preference for more expensive original biologics. Despite this, increased use of biosimilars can lead to better disease management, fewer hospitalizations, and overall improved patient outcomes.
The Future of Biosimilars in Inflammatory Disease Management
As the field of biosimilars continues to evolve, ongoing research and development are paving the way for new and innovative treatments. Advances in biotechnology and an improved understanding of disease mechanisms are driving the development of next-generation biosimilars, often referred to as 'biobetters.'
Biobetters aim to improve clinical outcomes and drug pharmacology compared to original biologics, addressing unmet needs in patients with immune-mediated inflammatory disorders (IMIDs). According to a Delphi Consensus meeting with 16 experts in IMIDs, biobetters focus on enhancing efficacy and pharmacology, though improvements in safety profile and patient acceptability were not considered crucial to their definition. An appropriate balance between clinical outcomes, costs, and shared decision-making between physicians and patients is also important when considering the use of biobetters. Ongoing clinical studies are required to validate this definition and assess their role in patient management.
The increasing availability of biosimilars is largely driven by the expiration of patents for reference biologic drugs, allowing for more affordable alternatives to enter the market. Ongoing clinical trials and regulatory advancements are expected to expand the range of biosimilars available, providing new therapeutic options for patients with diverse inflammatory conditions.
The adoption of biosimilars is steadily increasing across healthcare systems worldwide, and they have already made a significant impact on the treatment of RA, Crohn’s disease, UC as well as on other inflammatory diseases such as psoriasis, ankylosing spondylitis, and lupus. As more biosimilars receive regulatory approval and enter the market, their usage is expected to grow exponentially. Healthcare providers, payers, and patients are recognizing the value of biosimilars in improving access to affordable, effective treatments. This trend is likely to continue, with biosimilars playing an increasingly prominent role in the management of inflammatory diseases.
Conclusion
The advent of biologics and biosimilars has revolutionized treatment for patients suffering from inflammatory diseases, bringing renewed hope and improved quality of life. Continuous advancements in biosimilars, including the development of biobetters—next-generation biosimilars designed to enhance efficacy, safety, and patient convenience—promise even greater benefits for patients.
At iQone Healthcare Switzerland, we are committed to leveraging innovation and dedication to make a meaningful difference in patient health. Our mission is to ensure that biosimilars and breakthrough medicines are accessible to those who need them most.
After a decade of successful collaboration, Celltrion and iQone are now joining forces in an exciting new chapter. This integration represents a strategic move to ensure that iQone will be able to offer Swiss healthcare professionals extensive and diverse biosimilar portfolio. By combining our strengths, this vertical integration allows for greater control over key aspects of production and distribution.
To learn more about our biosimilar portfolio, please visit our website and don't hesitate to contact us for further information.