Choosing Wisely: Biosimilars vs. Reference Biologics in Switzerland

Prescription drug spending in Switzerland continues to rise, with biological medicines accounting for a significant share of the costs. Though these therapies offer essential treatments for conditions like rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, Crohn’s disease and more, their high cost places a growing burden on healthcare budgets.

According to a 2022 study published in JAMA Network Open, the median monthly treatment cost for reference biologics in Switzerland was USD $1,801 per patient, compared to USD $1,351 for biosimilars.

This financial pressure is partly due to the complexity of biologic medications. They are produced using living cells in tightly controlled manufacturing processes, making them more expensive to develop and distribute than traditional drugs. The result: higher biologic drug prices on the Swiss market and added pressure on healthcare systems already managing rising drug prices and limited budgets.

To ease this burden, many countries, including Switzerland, have introduced biosimilars. Biosimilars aim to provide equivalent treatment outcomes at a lower cost. We will talk about them more in the following chapters.

Uptake varies significantly across therapeutic areas: biosimilars in oncology and immunology show stronger market traction, while adoption in areas like diabetes care and metabolic disease remains low. Regional differences within Switzerland also play a role, with some cantons and hospital systems supporting biosimilar use more actively through procurement strategies and forms development.

These gaps have measurable consequences. According to the same report in 2023, Switzerland could have avoided CHF 90 million in healthcare costs through broader biosimilar use. Missed opportunities like this slow efforts to optimize healthcare costs, strain hospital budgets, and reduce the potential for improved access to cost-effective therapies.

But to understand how biosimilars fit into today’s treatment landscape, it’s important to start with a clear view of how they differ from the reference biologics they’re designed to substitute.

What are biosimilar medicines?

According to the Swiss Therapeutic Products Act (TPA), a biosimilar is defined as "a biological medicinal product sufficiently similar to a reference preparation authorised and that refers to its documentation."

In other words, biosimilars are similar versions of already approved biologic medicines, developed to match their reference products in terms of quality, safety, and efficacy.

The development of a biosimilar is a regulated process that begins before the expiry of the exclusivity of a reference medicine.

In Switzerland, all biosimilar medicines are approved by Swissmedic. This authority follows a stepwise approval process to ensure therapeutic equivalence to the reference drug.

What’s the difference between reference biologic and biosimilars?

Biologics, including targeted therapies such as monoclonal antibodies, have helped transform treatment approaches for various autoimmune diseases and cancers. Because they are made from living organisms, biologics are highly sensitive to manufacturing conditions and require careful handling to ensure product consistency.

While the core therapeutic goal of biosimilars and reference biologics remains the same, their development strategies differ. Biosimilars are built to match the reference biologic’s structure and function as closely as scientifically possible, using a reverse-engineering model that relies on existing knowledge of the reference drug.

The distinction lies in the starting point: reference biologics are developed through original discovery, while biosimilars are designed to mirror an existing treatment. This difference makes biosimilars faster and more cost-effective to develop, while still meeting strict requirements for therapeutic equivalence.

Why biosimilars are not the same as generic drugs?

While generic and biosimilar medicines both aim to expand access to treatment at a lower cost, they are fundamentally different. Generics are exact chemical copies of their reference medicines. They are small, simple molecules that can be synthesized identically and are typically approved based on bioequivalence studies in healthy subjects without additional clinical studies.

Unlike generic versions, biosimilars are biologically derived and naturally variable. Pharmaceutical companies must show that these differences have no impact on safety, potency, or immunogenicity. This is why biosimilars undergo a distinct approval pathway, with quality, functional, and clinical data reviewed by regulators like Swissmedic.

Biologics are the result of full-scale drug research and development programs. This includes target identification, early research, and multiple phases of clinical trials across different patient populations. The process typically spans more than a decade and requires substantial investment.

Biosimilars, on the other hand, are developed before the patent or exclusivity period for a reference biologic has expired. Because the reference product has already demonstrated safety and efficacy, the goal of biosimilar development is to prove similarity rather than to provide exhaustive data confirming its efficacy and safety. This is done through a stepwise comparability exercise, beginning with structural and functional analyses and extending to targeted trials.

Because biosimilars avoid the time, cost, and risk of early-stage development, they typically enter the market at a lower price.

Access to treatment is also shaped by how quickly healthcare institutions adapt to changes in policy. Even when biosimilars treat the same conditions as their reference products, delays in market entry or slow uptake can limit their impact on Swiss healthcare.

Substituting reference biologics: what swiss law now allows

Until recently, retail pharmacists in Switzerland were not allowed to substitute prescribed biologic medicines with biosimilars at the retail pharmacy level. Unlike generics, reference biologics required explicit prescriber approval, even when a reimbursed biosimilar alternative was available.

This changed in January 2024, when an amendment to the insurance ordinance introduced new provisions for substitution. Under the updated regulation, pharmacists may now substitute certain reference biologics with an approved biosimilar, provided specific criteria are met.

The aim of this policy update is to help reduce unnecessary drug costs while maintaining the quality of care. It aligns with the broader effort to optimize healthcare spending through more efficient use of approved biosimilars.

While substitution is not yet universal, the 2024 rule change represents an important shift in Switzerland’s approach to biosimilar substitution. It introduces a lever for cost containment, one that depends not only on regulatory allowance, but also on communication between prescribers, pharmacists, and patients.

Policy changes enabling biosimilar substitution in Switzerland are designed to support more affordable biologic treatment and improve access for both healthcare professionals and patients.

Are biosimilars really as effective? what the data shows

The effectiveness and safety of biosimilars are often a focus of discussion, particularly in clinical settings where reference biologics have been in use for years. To address this, regulators require a detailed comparison between the biosimilar and its reference product, guided by well-established scientific criteria.

According to both Swissmedic and the EMA, a biosimilar must demonstrate no clinically meaningful differences from its reference biologic drugs in terms of safety, efficacy, and immunogenicity. This is confirmed through a stepwise development process that includes comparative analytical testing, non-clinical data, and at least one clinical trial in a target patient population. The World Health Organization (WHO) supports this model and has issued guidelines to promote the use of quality-assured biosimilars.

In the EU, more than 90 biosimilars have been approved by the EMA across multiple therapeutic areas. In Switzerland, 43 biosimilars had been approved by Swissmedic as of December 2023, reflecting a steadily expanding portfolio of treatment options aligned with European standards.

A 2019 review by the European Commission concluded that biosimilars approved in Europe had comparable safety and efficacy profiles to their reference drugs, with no unexpected differences emerging from post-marketing surveillance.

For healthcare professionals evaluating treatment options, this body of evidence supports the conclusion that approved biosimilars offer a reliable and clinically validated alternative to their reference counterparts. In clinical practice, many healthcare professionals now consider biosimilar products as interchangeable in terms of expected patient outcomes, particularly where robust post-approval evidence supports safety and efficacy.

Why it pays to switch: economic benefits in swiss context

The difference in cost between biosimilars and reference biologics has direct consequences for the Swiss healthcare system.

According to the 2024 Biosimilar Barometer, Switzerland realized CHF 707 million in savings through biosimilar and generic substitution and annual price adjustments. However, CHF 180 million in additional savings remains untapped, largely due to inconsistent adoption and underuse of reimbursed biosimilars.

These figures point to a missed opportunity. Although biosimilars are approved, reimbursed, and clinically equivalent to their reference products, they are not used at the same rate across all therapeutic areas. In some hospital settings, particularly where tender processes or procurement contracts are already in place, biosimilars are gaining ground. In others, prescribing habits and lack of familiarity continue to limit uptake.

For cantonal systems and public hospitals, continuing to choose higher-priced originators when equivalent biosimilars are available has a measurable impact on annual budgets. The price gap between reference biologics and biosimilars reflects both the complexity of initial drug discovery and the opportunity to ease budget pressure by adopting lower-cost alternatives.

Improving adoption requires more than regulatory approval. It depends on consistent procurement policies, clinical confidence, and clear guidance on substitution. The recent change in the insurance ordinance offers one pathway forward, but broader progress will depend on how quickly stakeholders align around the value of switching.

Final thoughts: time to rethink the status quo

Biologic medicines have brought clear clinical benefits to patients in Switzerland. But when biosimilar alternatives are available, approved, and reimbursed, continuing to rely solely on reference products raises important questions, particularly about cost management and long-term sustainability.

Many hospitals and cantonal systems are already adjusting their purchasing strategies to include biosimilars. For others, this may be the time to evaluate existing protocols and consider whether current prescribing patterns reflect the full range of available options.

For healthcare teams looking to evaluate their options, iQone offers a portfolio of approved biosimilars in oncology, onco-haematology, rheumatology, gastroenterology, pneumology, allergology and dermatology. To stay informed about developments in biosimilar adoption and access, visit iqone-healthcare.com or contact our team.

Overspending on Reference Biologics FA

Are biosimilars as effective as reference biologics?

Yes. Biosimilars approved by Swissmedic and the EMA must demonstrate no clinically meaningful differences in safety, efficacy, or immunogenicity compared to their reference drugs. This is established through analytical studies, preclinical data, and at least one phase 3 clinical trial in an approved indication

How much do biosimilars cost compared to reference biologics in Switzerland?

Biosimilars enter the market at a lower price than the reference biologics, often at least 20% less. The exact price difference varies by molecule, therapeutic area, and market size in Switzerland, but biosimilars typically offer a lower-cost alternative when multiple suppliers are competing. These differences are reflected in the Specialities List pricing.

Can pharmacists substitute reference biologics in Switzerland?

As of January 2024, pharmacists in Switzerland may substitute certain reference biologics with biosimilars under defined conditions. This is permitted when the biosimilar is included on the Specialities List, meets clinical equivalence requirements, and the prescribing physician has not explicitly excluded substitution.

Why are reference biologics still being used if biosimilars are cheaper?

Several factors influence prescribing, including clinical familiarity with reference products, historical procurement contracts, and caution around substitution. While biosimilars are widely approved and reimbursed, adoption remains uneven across therapeutic areas and institutions.