Biosimilar medicines – EU and Polish perspective

Publication date: June 06, 2023


Biosimilar medicines, also known as biosimilars, are used in medicine to treat severe and chronic conditions such as cancer, diabetes and autoimmune diseases. Biosimilars – true to their name, they are similar to existing biological reference drugs. They are produced using living organisms or their cells, such as proteins, antibodies and other biological substances. These pharmaceuticals are also produced using biological processes but are not identical to the original reference medicines.

Biosimilars must meet certain criteria to be approved by the relevant regulatory authorities. They must be similar in quality, efficacy and safety to reference medicines. This means that they must have similar biological properties, such as action, mode of action and side effects, to those of the reference drugs.

The approval process for biosimilars is more complex than for traditional synthetic medicines because biosimilars are more complex to manufacture and have greater variability. Many jurisdictions have specific guidelines and regulations for biosimilars to ensure proper testing, quality assessment and safety of these drugs.

Biosimilars are of great importance in therapy because they can be used as an alternative to expensive reference biological drugs, which are often used to treat conditions such as rheumatoid arthritis, autoimmune diseases, cancer and other serious diseases. Access to biosimilars can increase the availability of treatment and reduce treatment costs, which is especially important in the case of biologics, which are usually more expensive than traditional synthetic drugs.

  • Biosimilars vs Biologicals – What’s the Difference?

Biologics are produced using advanced biotechnology methods that often use complex cell systems and recombinant DNA technology. Biosimilars are similar, but not identical, to biologics. Here are some major differences between them:

In terms of the manufacturing process, biologics are produced using living organisms such as cells or microorganisms. Their production process is complex and involves many steps, including cell culture, extraction of the active substance and purification processes. On the other hand, biosimilars are produced according to similar processes but by different pharmaceutical companies. This means that biosimilars are not identical copies of biological drugs, but they are similar in composition and action.

When it comes to regulatory approval, biologics go through a long and rigorous approval process by regulatory bodies such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Biosimilar medicines also have to go through similar approval processes, but they usually use the results of research done for the original biological medicine, called the reference medicine. Biosimilar medicines are tested to show that they are similar to the reference medicine in terms of quality, effectiveness and safety.

Conversely, in the case of patent protection, biological drugs are often protected by patents, which means that other manufacturers cannot manufacture and sell identical products for a certain period of time. In the case of biologics, patent protection can be more complicated as they consist of more complex molecules and manufacturing processes.

  • Division of biosimilars

Biosimilars are based on biologically active substances such as proteins, antibodies and peptides. They have similar properties and efficacy to original biologics, also known as reference or originator biologics.

There are many different types of biosimilars, including but not limited to:

Biosimilar anticancer drugs: These are biosimilar drugs used in cancer therapy. They may include biosimilar forms of drugs such as trastuzumab, rituximab, bevacizumab or filgrastim, which are used to treat various types of cancer.

Biosimilar immunosuppressants: Biosimilar medicines used to suppress the immune system in organ transplants. Examples include biosimilar forms of drugs such as infliximab and etanercept, which are used to treat autoimmune diseases and prevent transplant rejection.

Biosimilar hormones: Biosimilar medicines that include hormones such as insulin, somatropin (growth hormone) or levothyroxine (thyroid hormone). They are used in the treatment of endocrine diseases such as diabetes or hypothyroidism.

Biosimilar hematopoietic agents: These are biosimilar drugs used to treat diseases of the hematopoietic system, such as anaemia, neutropenia and thrombocytopenia.

  • Cost of therapy with biosimilar drugs

Biosimilar therapy can usually be less expensive than biologics, but the costs can still be significant. Biological drugs are often very expensive due to the complicated production process, high costs of clinical trials and the development and maintenance of production technologies. In addition, many biologics are protected by patents, which reduces competition and keeps prices high. This can result in significant costs for patients, healthcare systems and insurers.

The introduction of biosimilar drugs to the market may help to reduce the cost of biological therapy. Competition between biosimilar manufacturers and originator biologics can lead to lower biologics prices. In many cases, biosimilars are introduced to the market after biologics patents have expired, which opens the door to price competition.

It is worth noting, however, that the cost of biosimilar therapy may vary by region and healthcare system. In some countries where competition and access to biosimilars are more developed, treatment costs may be lower.

  • Efficacy of therapy with biosimilar drugs

Treatment with biosimilar medicines can be as effective as treatment with biological medicines, as long as they meet the appropriate standards of quality, efficacy and safety. Before biosimilars can be placed on the market, they must undergo rigorous testing to demonstrate that they are similar to the reference biological medicine.

Clinical trials of biosimilars include evaluating their pharmacokinetics (how the drug is absorbed, distributed and excreted from the body), pharmacodynamics (how the drug works in the body), and safety and efficacy compared to the reference biological drug. These studies are designed to show that a biosimilar works in a similar way and achieves the same therapeutic effects as a biological medicine.

Regulatory agencies, such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA), check the results of clinical trials and decide whether biosimilars should be allowed on the market. They also assess the manufacturing quality of biosimilars to ensure they meet the appropriate standards.

In clinical practice, biosimilars are used to treat the same diseases and conditions that biologics are used for. Patients who receive biosimilars can expect similar efficacy compared to biologics if the biosimilars are properly approved and clinically tested.

It is worth noting, however, that the response to biosimilar therapy may vary from patient to patient. As with biologics, some patients may be more effectively treated with biosimilars, while others may require a different treatment. It is important that the treating physician assesses the appropriate drug and dosage depending on the individual needs of the patient.

  • European Medicines Agency

The European Medicines Agency (EMA) plays a key role in the approval of biosimilar medicines in Europe. Here is more detailed information on this:

Central Authorization Procedure: EMA is the regulatory agency of the European Union responsible for evaluating and authorizing medicines. When a manufacturer wants to introduce a biosimilar medicine to the European market, it can submit it to the Central Authorization procedure, which covers all EU Member States, Iceland, Liechtenstein and Norway. This procedure is mandatory for certain types of medicines, including most biological medicines, including biosimilars.

Documentation assessment: As part of the Central Approval procedure, EMA conducts a thorough assessment of the documentation provided by the biosimilar manufacturer. This documentation includes the results of clinical and non-clinical studies, information on the quality, effectiveness and safety of the drug, as well as information on the manufacturing process. EMA analyzes this data to assess whether the biosimilar medicine meets the appropriate quality standards and is effective and safe compared to the reference biological medicine.

EMA is developing guidelines and standards for the assessment of biosimilar medicines. It defines the requirements for clinical trials, drug quality, appropriate models for comparing biosimilars with biological drugs, and other issues related to safety and efficacy. These guidelines help manufacturers of biosimilar medicines to provide relevant data for assessment by the EMA.

EMA has specific scientific committees, such as the Committee for Biotechnology-Produced Medicinal Products and the Committee for Biotechnology-Produced Medicinal Products, which are responsible for evaluating biosimilar medicines. These committees consist of experts from various fields of medicine and science who evaluate the documentation provided, conduct analyzes and make recommendations regarding the approval of biosimilars.

Decision on approval – based on the assessment of documentation and recommendations of scientific committees, EMA makes a decision on approval of a biosimilar medicine.

  • Are biosimilar drugs reimbursed in Poland by the Polish National Health Fund?

Biosimilars are reimbursed in Poland by the Polish National Health Fund (Polish: NFZ), which means that the costs of treatment with biosimilars are partially or fully covered by the state health care system.

In Poland, the process of reimbursement of biosimilars is regulated by the Pharmaceutical Law and regulations on drug reimbursement. Reimbursement decisions are made by the Commission for Registration of Medicinal Products, Medical Devices and Biocidal Products at the Ministry of Health. This committee is an independent body of experts who assess drug manufacturers’ applications for reimbursement.

The basic criterion that biosimilars must meet in order to be reimbursed is to document therapeutic equivalence with the reference biological drug. This means that a biosimilar drug must demonstrate that it has a similar therapeutic effect, efficacy and safety as the biological drug it refers to. The biosimilar manufacturer must provide the relevant data, clinical trial results and other information to confirm therapeutic equivalence.

A positive reimbursement decision means that the biosimilar drug is entered on the List of Reimbursed Drugs, which is regularly updated by the National Health Fund. Physicians can then prescribe a biosimilar drug to patients, and the costs of treatment are covered by the National Health Fund to a certain extent. It is worth noting, however, that the reimbursement of biosimilars may depend on specific therapeutic indications. This means that a biosimilar medicine can only be reimbursed for certain diseases or health conditions for which it is approved and its effectiveness has been documented.

In addition, the reimbursement of biosimilars may be subject to certain restrictions, such as setting quantitative limits, maximum prices or preferences for specific groups of patients (e.g. children, the elderly). These constraints are often set in order to optimize costs and effectively use available financial resources.

In the case of patients using the reimbursement of biosimilar drugs, it is often required to present relevant documents, such as a doctor’s referral, prescription or a certificate of the right to reimbursement of the drug.

In order to obtain detailed information on the reimbursement of specific biosimilars as well as the conditions and procedures related to their receipt, patients should consult the above issues with their doctor or pharmacist.

  • Are biosimilars only available on prescription?

Biosimilars are usually only available on prescription. In most countries, including Poland, biosimilars are classified as prescription drugs, which means that patients need a doctor’s prescription to purchase and use them.

The decision whether a biosimilar medicine is prescription-only depends on several factors, including the composition, potential side effects, the degree of risk associated with self-administration, and the recommendations of regulatory authorities. Biosimilar drugs, like biological drugs, are usually more complicated to manufacture and have potential side effects, so they are prescribed by doctors who can assess the individual situation of the patient and adjust the therapy to his needs.

A prescription is a document issued by a doctor that authorizes the patient to purchase a biosimilar drug in a pharmacy. In most cases, the patient must present the prescription to the pharmacist who will dispense the medicine. Prescriptions are controlled to ensure proper distribution and use of biosimilars and to minimize risk to patients.

It is worth noting that in some cases, depending on the country and national regulations, some biosimilars may be available without a prescription, but this is usually associated with restrictions on specific doses or therapeutic indications.

  • What legal status do biosimilars have in Poland?

In Poland, the legal status of biosimilars is regulated primarily by the Pharmaceutical Law Act and executive acts, such as the Regulation of the Minister of Health on the registration of medicinal products.

According to Polish law, biosimilars are treated as therapeutically equivalent to the biological drugs they refer to. This means that biosimilars have the same therapeutic properties and pharmacological effects as the biological drugs on which they are based. They have a similar molecular structure, chemical composition and mode of action.

The registration procedures for biosimilars in Poland are based on the guidelines of the European Medicines Agency (EMA) and the recommendations of the International Pharmaceutical Federation (FIP). The biosimilar manufacturer must provide comprehensive documentation, including the results of qualitative tests, in vitro and in vivo tests, results of clinical trials, and information on the production process and quality control.

The Polish Commission for Registration of Medicinal Products, Medical Devices and Biocidal Products is the body responsible for evaluating manufacturers’ applications for the registration of biosimilars in Poland. The committee consists of experts from various fields, such as pharmacology, toxicology, pharmacokinetics, microbiology, clinical medicine, etc. They assess the completeness and reliability of the documentation provided by the manufacturer and conduct a scientific analysis to assess the therapeutic equivalence of the biosimilar medicine with the reference biological medicine.

A positive decision of the Commission on the registration of a biosimilar medicine means that this medicine receives the status of a legal medicinal product and can be introduced to the market in Poland. Depending on the specificity of the biosimilar, the registration may cover the full range of therapeutic indications or be limited to specific indications for which the biosimilar has been documented as effective and safe.

In the case of reimbursement of biosimilars by the National Health Fund, the Commission for Registration of Medicinal Products, Medical Devices and Biocidal Products also plays an important role. It is on the basis of the decision of the Commission for Registration of Medicinal Products, Medical Devices and Biocidal Products that a biosimilar drug can be entered on the List of Reimbursed Medicines, which enables patients to access this drug and partially or completely cover the costs of treatment by the National Health Fund.

It is worth noting that the registration and reimbursement system for biosimilars in Poland is constantly being developed and adapted to the changing national and European regulations. The goal is to ensure patient safety, effectiveness of therapy and access to modern and innovative biosimilar drugs.

  • EU regulations and biosimilars

Biosimilars are regulated at the European Union level by legislation that ensures consistency and standards for these products. The key legal document for biosimilars is Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and guidelines of the European Medicines Agency (EMA).

Regulation (EU) No 726/2004 provides the legal framework for the procedures related to the registration, evaluation, authorization and supervision of veterinary and human medicines at European Union level. Under this Regulation, there is implemented the so-called centralized procedure that enables obtaining a single, joint authorization to place a drug on the market in all EU Member States.

In the case of biosimilars, the centralized procedure plays a special role. The manufacturer must submit an application for authorization to place a biosimilar medicine on the EU market to the European Medicines Agency (EMA). EMA, acting in cooperation with the Committee for Medicinal Products for Human Use, conducts a scientific assessment of the quality, efficacy and safety of a biosimilar medicine.

The assessment includes a comprehensive analysis of preclinical data, clinical trial results, and information on the manufacturing process and quality control. The Committee for Medicinal Products for Human Use compares the biosimilar medicine with the reference biological medicine in terms of quality and therapeutic similarity. The Committee’s positive opinion is forwarded to the European Commission, which makes the final decision regarding authorization to place the drug on the EU market.

The EMA guidelines are also an important document for biosimilars. EMA develops and publishes guidelines for the testing and evaluation of biosimilar medicines, which serve as a framework for manufacturers to report and document data. The EMA guidelines cover various aspects such as quality, bioavailability, pharmacokinetics, immunogenicity, therapeutic effectiveness and safety.

EU legislation on biosimilars is designed to ensure the consistency, safety and quality of these products across the European Union. They also ensure the harmonization of registration processes and scientific evaluation of biosimilars in different Member States.

EU regulations and legal regulations regarding biosimilars

The EU legislation on biosimilars provides a general framework and guidance for the Member States of the European Union, which are required to implement these provisions into their national legal systems. Polish legal provisions relating to biosimilars are therefore part of the national legal system, which is compliant with EU requirements, but may differ in some details.

The first difference is that EU rules such as Regulation (EU) No 726/2004 apply to all EU Member States. This means that the guidelines and rules for the registration, evaluation and supervision of biosimilars are consistent across the European Union. Polish regulations, however, are specific to Poland and include detailed regulations regarding the registration, reimbursement, monitoring and control of biosimilars in the country.

Another difference is the implementation of EU rules by Member States. Although Poland is obliged to comply with EU requirements, the way of implementing and interpreting these provisions may differ slightly. The Polish legislation on biosimilars may contain additional details or national procedures that must be followed by manufacturers and regulatory authorities in Poland.

In addition, Polish regulations may introduce additional requirements regarding documentation, clinical trials, registration and reimbursement of biosimilars that are specific to the Polish healthcare system and pharmaceutical regulations. These differences may be due to national circumstances, such as therapeutic preferences, reimbursement policies, registration procedures, and resource availability.

It is worth noting that despite some differences between EU and national regulations, Poland strives to ensure compliance with EU requirements and adapt its pharmaceutical regulations to European standards. The aim is to ensure the consistency, safety and quality of biosimilars in Poland and to facilitate patients’ access to modern biological therapies.