When can biological drugs be used?

Biological drugs, such as proteins, hormones, and antibodies, unlike other drugs, are obtained from biological material and not by chemical synthesis.
But when can they be used? Are they effective? Are there any contraindications? And is it true that they're too expensive?

Index of topics

What is

Doctor and patient during evaluation for biological drugs

I biological drugs They are medicines produced using living cells, biological tissues, or organisms modified using biotechnological techniques. Unlike traditional drugs, which are obtained through chemical synthesis, they are the result of much more complex and delicate manufacturing processes.

Among the best known are the monoclonal antibodies, some forms of insulin, hormones used in oncology, and treatments for autoimmune diseases. They are used primarily in chronic or severe conditions where traditional treatments fail to adequately control symptoms.

According to Humanitas specialists, particularly in their in-depth analyses of monoclonal antibodies and chronic inflammatory diseases, the key characteristic of biologic drugs is their ability to target very specific areas of the immune system or inflammatory processes. For this very reason, they require careful monitoring, periodic follow-up, and a specialist prescription.

Some of these therapies are also used against chronic migraine: they are monoclonal antibodies produced in the laboratory and directed against the protein CGRP, a molecule involved in the mechanisms of pain transmission and migraine attacks.

How do they work

The mechanism of action of biological drugs is different from that of traditional medications. In many cases, these therapies act in a targeted manner, blocking molecules responsible for inflammation, pain, or immune system alterations.

This is one of the reasons why biologics have found application in diseases such as rheumatoid arthritis, Psoriasis, Crohn's disease, grave asthma, Some tumors and severe forms of migraineIn the case of anti-CGRP monoclonal antibodies, the treatment affects the mediators involved in the transmission of pain sensation.

According to a review published in the New England Journal of Medicine, several anti-TNF biologics have demonstrated efficacy in controlling inflammation and reducing disease progression in patients with rheumatoid arthritis and other autoimmune diseases. Studies published in The Lancet Neurology on anti-CGRP monoclonal antibodies have shown a significant reduction in the frequency of attacks in chronic migraine patients selected for these treatments.

This doesn't mean, however, that biologics are suitable for everyone or that they always work the same way. Therapeutic response varies from patient to patient and requires ongoing monitoring.

When can they be used?

I biological drugs They are used above all when traditional therapies do not produce sufficient results or cause significant side effects.

Their prescription follows very strict criteria defined by health authorities and scientific societies. In many cases, the patient must first try other treatments.

Even for the most severe forms of migraine, biologics can only be prescribed to patients with particularly disabling symptoms and after the failure of some traditional preventive therapies, according to very rigorous clinical criteria established by specialists.

The goal is to avoid unnecessary or excessive treatments and to use these drugs only when the clinical benefit can be truly significant. This principle also applies to the concept of do not waste: making better use of healthcare resources, without turning every innovation into an automatic therapy.

The effectiveness

The effectiveness of biologics is documented by numerous scientific studies, but must be evaluated on a case-by-case basis. In some conditions, these drugs have significantly improved patients' quality of life.

For example, in chronic forms of migraine, many patients treated with monoclonal antibodies experience a reduction in the frequency of attacks already within the first few months of therapy.

Even in autoimmune diseases the results can be important, especially in reducing chronic inflammation and preventing worsening of the disease.

However, both the Mario Negri Institute and Humanitas emphasize that biologics are not definitive or miracle cures. Some patients don't respond to therapy, while others may lose efficacy over time. For this reason, periodic checkups and a continuous evaluation of the benefit-risk balance are necessary.

After a few months of treatment, therapies may be temporarily suspended to see if the benefit persists.

Costs

One of the most discussed aspects of the biological drugs it concerns the price. In fact, it is about very expensive medicines, because they require advanced research, sophisticated technologies and complex production processes.

According to industry estimates, the Italian biopharmaceutical market is worth approximately $8,5 billion in 2024 and could exceed $10 billion in 2025. At the same time, public pharmaceutical spending on innovative therapies is also growing.

The risk is that speculative phenomena will also develop around biological drugs, with very high prices that could put pressure on the National Health Service and increase inequalities in access to care.

Some organic treatments, especially the more innovative ones, can cost several hundred euros per month if purchased privately.

For this reason, the issue of costs concerns not only patients, but the entire balance of the public healthcare system. Therapeutic innovation and economic sustainability must go hand in hand.

National Health Service coverage

Biosimilar drugs used in hospital settings

Many biological drugs are covered by the National Health Service, but only in the presence of specific clinical conditions and after a very rigorous specialist evaluation. Therefore, these drugs are not automatically accessible to all patients, precisely because they are expensive and require ongoing monitoring.

Prescriptions are generally issued through hospitals or authorized specialized facilities, following protocols defined by AIFA and scientific societies. In many cases, patients must demonstrate that they have already undergone other therapies without achieving sufficient results or have developed side effects that require a change in treatment.

For some conditions, national monitoring registries are established to verify therapeutic appropriateness, drug efficacy, and the occurrence of adverse reactions. This system serves both to protect patients and to prevent the misuse of very expensive medications.

The issue also concerns the sustainability of public healthThe increase in innovative therapies represents one of the main drivers of growth in Italian pharmaceutical spending. For this reason, controlling prescriptions is considered essential to ensuring effective treatments without compromising the balance of the healthcare system.

The expiration of some patents

In recent years the expiry of patents on several biological drugs has favoured the spread of the so-called biosimilars, drugs very similar to the original biologics but generally less expensive. This is an important step because it could make these therapies more accessible and reduce the financial pressure on the National Health Service.

Biosimilars, however, are not identical copies like traditional generic drugs. The manufacturing processes for biologics are much more complex, because they rely on living cells and sophisticated technologies. Even small variations in manufacturing can affect some characteristics of the final product.

For this reason theEuropean Medicines Agency (EMA) It requires very rigorous controls: biosimilars must demonstrate comparable quality, safety, and efficacy to the reference drug before they can be authorized.

According to several healthcare experts, the spread of biosimilars could help curb the growth of public pharmaceutical spending and reduce pharmaceutical waste in Italy, improving the accessibility of care without compromising therapeutic quality. This is a delicate challenge, where innovation, economic sustainability, and the right to healthcare must find a credible and lasting balance.

Controindicazioni

Biological drugs can have side effects also important and must always be used under specialist supervision.

Possible contraindications include infections, altered immune response, allergic reactions, and increased vulnerability to certain infectious diseases.

Not all patients can take these medications. In the presence of active infections or specific immune conditions, some biological therapies are not recommended or require very careful consideration.

For this reason, the choice to use a biological drug must always be personalized, based on scientific evidence, and accompanied by periodic monitoring. It is one of the most important innovations in modern medicine, but also a therapeutic tool that requires balance, rigor, and responsibility.