Everything You Need to Know About Biosimilars
In recent years, the healthcare sector has seen a significant increase in the adoption of biosimilar drugs. This adoption is primarily driven by the fact they offer a cost-effective alternative to high-priced biological medicines, which is important for patients with chronic and life-threatening conditions who depend on these treatments.
Biosimilars are distinct from traditional generic drugs. They are complex proteins synthesized from living cells, engineered to be highly similar to their reference biologic drugs, matching them in safety, efficacy, and quality.
The market entry of biosimilar medicines has sparked a series of discussions, especially concerning their regulation, naming, interchangeability, and the policies around their substitution. This article will dive into the world of biosimilar drugs and discuss everything you need to know about them and their development, approval process, and impact on the healthcare industry.
What Are Biosimilars?
You may be familiar with a class of drugs called biologics. Biologics are medicinal products derived from various natural sources, including humans, animals, or microorganisms. They include a wide range of products like vaccines, blood components, gene therapy products, tissues, and recombinant therapeutic proteins.
Unlike traditional small-molecule drugs synthesized chemically, biologics are composed of large molecules. They require complex research, development, and manufacturing, making them very distinct in their creation, application, and approval.
This definition highlights the core concept of biosimilarity: even though perfect replication is impossible due to the natural variability of living cells, biosimilars must match their reference products in clinical performance. They contain the same active ingredients as the original biologic drugs and are only introduced to the market after the original drug's patent expires.
To develop a biosimilar, you have to have a deep understanding of the reference product's molecular characteristics, biological activity, and clinical profile. You have to demonstrate that the biosimilar is "comparable" to its reference product through extensive analytical, non-clinical, and clinical studies, which we will discuss in more detail later.
Biosimilars vs. Generic Medications
If you’ve heard of biological medicines, you’ve probably also heard about generic drugs. Generic drugs are identical copies of brand-name drugs but with a different name and are usually offered at a lower price. They work in the same way and contain the same active ingredients but are produced by different manufacturers. In other words, a generic drug is an identical substitute for its brand-name counterpart.
So, what makes biosimilars different from both generic drugs and their reference biologics? Unlike generic versions, biosimilars are not exact copies of their reference biologic drugs due to the inherent complexities of biological production.
Before we move on to the main features that differentiate them, take a look at a detailed comparison to illustrate the requirements and processes involved for originator biologics, biosimilars, and generic drugs.
From this table, it’s evident that biosimilars undergo a rigorous evaluation process that mirrors their reference biologics much more closely than generics do with their counterparts. This makes the development and approval of biosimilars more complex and meticulous than that of generic drugs.
Now, with this groundwork laid, let’s take a deeper look at three key features in which biosimilars and generic medications differ:
Manufacturing Process
Generic drugs are manufactured through a chemical synthesis process, which allows for consistent and identical replication of the original drug's active ingredients. On the other hand, the inherent nature of biological production involves complex biochemical processes within living cells, which are sensitive to slight changes in manufacturing conditions.
These conditions include variations in temperature, pH levels, nutrients in the growth medium, and even minor discrepancies in the handling techniques. Each of these factors can influence how the cells grow and produce the biologic molecules.
Moreover, the purification process, designed to isolate the active biological substances from the host cells and other by-products, can also introduce variations. Because living organisms are involved, replicating the exact biological environment and processes from batch to batch is challenging, leading to variability in the final product.
This natural variability is why biosimilars cannot be exact copies of their reference biologics, and why rigorous testing and comparison are necessary to ensure they meet the same standards.
Source: https://www.nationalmssociety.org/Treating-MS/Medications/Generic-and-Biosimilar-Medications
Approval Process
The approval process for generic drugs is relatively straightforward and generally requires only bioequivalence studies. These studies are designed to prove that the generic drug has the same active ingredients and works in the same way as the brand-name drug, focusing mainly on ensuring that the drug reaches a similar concentration in the bloodstream and at a similar rate as the original.
Biosimilars, however, undergo a rigorous approval process that mirrors many of the same stages required for the originator biologics. This includes extensive quality assessments and both non-clinical and clinical studies. Non-clinical evaluations involve in vitro and, if necessary, in vivo studies to assess biological activity. Clinical studies for biosimilars focus on pharmacokinetics and pharmacodynamics, similar to the originator, but typically do not require Phase II trials.
Both the originator and the biosimilar must undergo Phase III clinical efficacy and safety trials to ensure therapeutic equivalence and safety. Furthermore, both are subject to ongoing pharmacovigilance to monitor safety and effectiveness post-approval.
Interchangeability
When it comes to Switzerland, the substitution of biologics with biosimilars presents a distinct regulatory approach compared to generic medications, as the interchangeability of biosimilars with reference biologics is a bit more complex.
As of January 2024, Swiss legislation has been revised to allow pharmacists to substitute biologics with biosimilars with the same active ingredient, under specific conditions outlined in the Health Insurance Act. This marks a significant shift, as previously, only prescribing doctors could initiate such substitutions based on a detailed assessment of individual patient needs and the therapeutic equivalence of the biosimilar.
However, despite this legal allowance for pharmacist-led substitution, it is important that both pharmacists and prescribing healthcare providers closely monitor patient responses and consider any potential risks or benefits.
This careful consideration is essential because even slight variations in the biosimilar manufacturing process can influence patient outcomes. As such, while pharmacists are now empowered to make these substitutions, the overarching guidance from Swissmedic underscores the need for patient-specific assessment in the interchangeability of biosimilars.
The Role of Biosimilars in Modern Medicine
The emergence of biosimilars is reshaping not just individual patient care but the entire healthcare landscape. In Switzerland, the integration of generics and biosimilars has led to substantial cost savings and prompted a series of legislative and policy adjustments aimed at further boosting their use.
The integration of generics and biosimilars has led to savings of approximately 679 million CHF in 2023. Nevertheless, the uptake of biosimilars is still not as widespread as expected. According to the recent biosimilar barometer report, despite the available biosimilars, Switzerland still missed out on potential savings of 90 million CHF in 2023. This missed opportunity stems from the continued preference for more expensive original biologics, which still accounted for half of all cases where cheaper biosimilar alternatives were available.
Recognizing the necessity to enhance biosimilar adoption, Swiss authorities have implemented several measures effective from 2024. These include, as already mentioned, enabling pharmacists to substitute original biologics with biosimilars, applying differentiated deductibles to encourage patients to opt for biosimilars, ensuring cost credits cover both biologics and their biosimilars, and revising the distribution margins for medicines to eliminate financial disincentives for prescribing biosimilars.
Beyond reducing healthcare costs, biosimilars enhance patient access to necessary biologic treatments by breaking down financial barriers. In Switzerland, the market share of biosimilars reached approximately 56% by volume in 2023, with individual biosimilars like Bevacizumab achieving up to 69% market share. This increased accessibility is expected to continue growing as more biologic patents expire and new biosimilars enter the market, promising a future where healthcare systems can sustainably manage the high costs associated with biologic medications.
Furthermore, the competition driven by biosimilars not only fosters innovation within the biopharmaceutical industry but also leads to advancements in manufacturing processes and technology. This cyclical dynamic ensures the continual development of biologic drugs, improving outcomes and efficiencies across the board.
Ultimately, the strategic integration of biosimilars into clinical practice and healthcare policy reflects a significant shift towards more sustainable health systems in Switzerland and beyond. This shift is supported by comprehensive monitoring and effectiveness checks, such as those facilitated by the biosimilar barometer, ensuring that the policies enacted to promote biosimilars achieve their intended goals.
Expanding Treatment Options With Biosimilars
Biosimilars are employed across various medical specialties to treat chronic and serious health conditions, reflecting the diverse applications of their reference biologics. While the specifics of each biosimilar depend on its approved indications, these treatments are commonly found in fields including:
- Rheumatology
- Gastroenterology
- Dermatology
- Ophthalmology
- Oncology
In rheumatology, biosimilars are used to manage conditions like rheumatoid arthritis, where they help reduce inflammation and slow disease progression. They are similarly employed in gastroenterology to treat chronic bowel diseases like Crohn’s disease and ulcerative colitis, offering patients relief and maintaining quality of life.
Dermatologists use biosimilars to address chronic skin conditions, including psoriasis, by modulating the immune response to reduce symptoms and prevent flare-ups. In ophthalmology, biosimilars help manage diseases like age-related macular degeneration, providing essential treatments that preserve vision and prevent severe visual impairment.
Perhaps most significantly, in oncology, biosimilars play a pivotal role by increasing the availability of monoclonal antibodies used to target and neutralize cancer cells. This application is vital for improving patient outcomes in the treatment of various cancers, including breast, colorectal, and non-small cell lung cancers.
Approval Process and Safety of Biosimilars
In Switzerland, the approval of biosimilars is managed by the Swiss Agency for Therapeutic Products (Swissmedic), which has developed its own rigorous standards that, while informed by global practices, are tailored to meet the country’s specific healthcare needs and safety standards.
The approval process for a biosimilar in Switzerland begins with an exhaustive analytical assessment. This initial phase involves a detailed comparison of the biosimilar’s molecular and biological characteristics to those of the reference biologic. The assessment focuses on a range of attributes, including amino acid sequences, post-translational modifications like glycosylation patterns, and higher-order structures.
Following the analytical assessment, the biosimilar undergoes preclinical testing to evaluate its toxicity, pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted in the body), and pharmacodynamics (the biological effects of the drug on the body). These studies are critical for identifying any potential biological impacts before proceeding to clinical trials.
Clinical trials for biosimilars in Switzerland are comprehensive, covering pharmacokinetics and pharmacodynamics, as well as immunogenicity and safety profiles. These trials are designed to confirm that there are no clinically meaningful differences between the biosimilar and its reference product concerning safety, efficacy, and immunogenic response.
Additionally, Swissmedic mandates ongoing post-marketing surveillance to monitor the long-term safety and effectiveness of biosimilars. This surveillance detects any adverse effects that may not have been apparent in pre-approval studies and ensures that any potential risks are managed promptly and effectively.
The Future of Biosimilars with iQone Healthcare
The biosimilar market is expected to witness significant growth, driven by the expiry of patents for several leading biologics over the next few years. This will pave the way for new biosimilars to enter the market, increasing competition and further driving down the cost of biologic treatments.
Additionally, advancements in biotechnology are improving the efficiency and precision of biosimilar development, leading to even more robust and effective products. This could potentially expand the scope of biosimilars beyond just replicating existing biologic therapies, and open up opportunities for novel treatments.
Increased awareness and education about biosimilars among healthcare professionals and patients will also play a big role in shaping the future of this market. As more stakeholders become familiar with these products and their potential benefits, we can expect to see a greater acceptance and adoption of biosimilars in healthcare systems worldwide.
At iQone Healthcare Switzerland, we are driven by the belief that innovation, hard work, and effort have the power to improve the lives of those around us. Under the banner of "iQone for you," we focus on delivering high-quality biosimilars and innovative drugs that are specifically adapted to meet the needs of the Swiss market. As an independent specialty pharmaceutical company, our core mission is to ensure that therapeutic advances like biosimilars and breakthrough medicines reach the patients who need them, when they need them.
With one of the most comprehensive biosimilar portfolios in Switzerland, we are continuously diversifying with innovative new drugs, each designed to address a range of disease states. Our goal is to provide a distinct and holistic range of therapeutic options, addressing a variety of disease states and demonstrating our commitment to improving patient care and outcomes while underscoring our support for healthcare professionals and the Swiss healthcare system.
To learn more about our biosimilar portfolio and new product developments, please visit our website and don't hesitate to contact us for further information.
Biosimilars FAQs
What is the difference between a biosimilar and an original?
An original biologic is a complex product generated from biotechnological processes within living cells. A biosimilar is similar to the original biologic but only appears on the market after the reference product is no longer protected by a patent. A biosimilar is "similar" to the original in terms of efficacy, safety, and quality, as well as in the clinical sense; very slight variations can occur, however, because biosimilars are produced by living systems (cells).
Are biosimilars identical to the original biologics?
Biosimilars are not identical to their original biologics due to the inherent complexities and natural variabilities in the biological production process. Each biologic, including biosimilars, is produced in living cells, which can lead to slight variations in the biological molecules. Biosimilars are similar to their original biologics.
How effective is a biosimilar compared to the reference product?
They are equally effective, as shown by repeated clinical trials and as certified by Swissmedic. Because of their biological origin, biosimilars may vary slightly from one production run to the next, but any variations remain within very precise limits and in no way influence the products’ safety, efficacy, and quality.
Are biosimilars safe?
Yes, biosimilars are tolerated as well as reference products. They undergo rigorous testing and must meet stringent regulatory standards for safety, efficacy, and quality, similar to the original biologic drugs, before they receive approval.
Is there a price difference between a biosimilar and the original? Is the biosimilar reimbursed by insurance companies?
According to the Swiss Federal Office of Public Health (FOPH), biosimilars must cost at least 20% to 35% less than their reference products at the time of entry into the market (with some exceptions). Biosimilars are reimbursed by insurance companies depending on the individual situation.
Where can I find additional and detailed information about your biosimilar products and their use?
For more information on our products, feel free to contact us or visit the Swissmedic website.