6 challenges biosimilars bring to hospital management

To understand the biosimilar revolution, the origin of the word itself points the way. The term comes from the Greek bíos (life) and the Latin similis (similar). Unlike the absolute identity found in common chemical drugs, biosimilarity acknowledges the complexity of life, which can be replicated with extreme similarity but never with molecular exactness.

This article dissects biosimilars, showing their characteristics and general principles, their enormous potential in healthcare treatments and the economic impact they can bring.

What are biosimilar medications?

Biosimilars are biological products developed to be highly similar to a reference biological medication (the “original”) whose patent has already expired.

They are not just cheaper copies of a drug; they are complex medications that undergo rigorous testing to ensure they have no clinically meaningful differences in efficacy, safety or quality compared with the reference product.

Understanding biosimilars better

Imagine the design of a state-of-the-art commercial aircraft. If you try to replicate this plane, copying the external design is not enough. You need to reproduce the exact metal alloy, the response of the software systems under pressure and the performance of the engines at different altitudes.

Even if two planes come out of different factories and have millimetric variations, if they achieve the same aerodynamics and offer the same level of safety, they are functionally equivalent. In medicine, biosimilars are like these aircraft: complex biological machines that reach the same therapeutic destination.

What is the difference between biosimilars and generics?

This is a common question, and the distinction is crucial for patient safety. Generic medications are identical copies of synthetic drugs (chemical drugs), such as aspirin. They are small, stable molecules that are easy to reproduce from a chemical template. Biosimilar medications, on the other hand, are produced from living organisms (such as bacterial strains or mammalian cells). Because they are giant, dynamic molecules, they show natural microvariability.

Even batches of the original medication change subtly over time, which is why pharmaceutical science focuses on clinical similarity, that is, on ensuring that the outcome for the patient will be the same.

How is a biosimilar developed?

Developing a biosimilar is a rigorous, technical and highly regulated process. Unlike generics, the focus is not only on the final product but on the entire process of comparability with the reference medication.

The main stages include:

Extensive analytical studies

This phase assesses molecular structure, biological activity, purity and stability.

Nonclinical studies

In vitro tests (conducted outside a living organism, in a controlled laboratory environment) and, when necessary, in vivo tests (performed in living organisms, usually animals), to confirm similar mechanisms of action.

Comparative clinical studies

They demonstrate equivalence in pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity.

Only after robust proof of similarity can the product be approved by regulatory agencies.

Safety, efficacy and pharmacovigilance

The safety of biosimilars is backed by a robust body of scientific evidence accumulated over more than 15 years of use in several countries. Regulatory agencies such as the EMA, the FDA and Anvisa (Brazil’s National Health Surveillance Agency) apply rigorous, standardized criteria to approve these medications.

After they enter the market, biosimilars remain subject to active pharmacovigilance systems. Adverse events are continuously monitored, allowing any risk signal to be quickly identified and corrected.

In clinical practice, real-world studies have shown safety and efficacy profiles comparable to those of the reference biologics, which reinforces the reliability of these medications.

Interchangeability and therapeutic substitution

Interchangeability is one of the most debated topics in the context of biosimilars. It refers to the possibility of replacing the reference medication with a biosimilar, or vice versa, without harming the clinical outcome.

In Brazil, Anvisa does not establish interchangeability automatically. The decision remains the responsibility of the prescribing physician, taking into account scientific evidence, the patient’s history, clinical protocols and institutional guidelines. At hospitals and health plans, this decision is usually supported by technical committees that assess the clinical, economic and care impact.

Main areas affected by biosimilars

Biosimilars play a strategic role in therapeutic areas characterized by high-cost, long-term treatments. Oncology, rheumatology, gastroenterology, hematology and endocrinology account for a large share of the biological medications currently available.

In these specialties, the introduction of biosimilars has made it possible to expand access to treatment, shorten treatment waiting lists and enable the adoption of innovative technologies without compromising the financial sustainability of health systems.

Economic impact and health system sustainability

The main systemic effect of biosimilars is economic, but with direct repercussions on care. The entry of these medications into the market increases competition, puts pressure on prices and lowers the average cost of biological treatments, including the reference products.

This dynamic contributes to the sustainability of the public system, private healthcare and private hospitals, making it possible to treat more patients with the same budget. It also frees up resources for investment in innovation, infrastructure and improving care.

Biosimilars and hospital management

From a management standpoint, biosimilars introduce a new level of complexity. The decision to adopt them involves challenges such as:

1) analysis of clinical protocols;

2) contracts with payers;

3) impact on billing;

4) proper coding;

5) price negotiation;

6) strict inventory control.

Errors in this process can lead to denials, margin distortions and care conflicts. That is why efficient management of biosimilar use requires integration between the clinical, pharmacy, finance and administrative areas, with decisions based on reliable, up‑to‑date data.

The Rivio view

Biosimilars represent a convergence of clinical innovation and economic rationality. As their use expands, so does the need for control, predictability and intelligence applied to healthcare management. In this context, artificial intelligence solutions become essential to connect treatment protocols, medication use, contracts, billing and medical claims audit.

With Rivio’s AI platform, it is possible to automate the entire hospital revenue cycle: from care and medical audit to XML submission, including denial appeals after the payers’ review.

The platform was built to identify discrepancies, prevent invisible losses, reduce denials and ensure the hospital receives the full amount it is entitled to. By contract, Rivio commits to reimbursing the hospital 100% if a denial is not reversed.